Comparative Study of the Efficacy and Safety of Tigecycline Based Regimen Versus Colistimethate Sodium-based Regimen in Patients with Central Nervous System Bacterial Infections

This observational study compares the efficacy and safety of tigecycline, an alternative antibiotic with broad-spectrum activity, versus the standard colistimethate sodium-based regimen in managing these infections in pediatric patients.
Inclusion Criteria:
Pediatric patients aged 1 month to 18 years. Presence of CNS infection symptoms such as fever, altered mental status, and positive cerebrospinal fluid (CSF) findings.
EVD placement for managing CNS infections.
Exclusion Criteria:
Known allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results.
Neonates (less than 1 month old), pregnant, or breastfeeding patients.
Outcome Measures:
Primary Outcomes: Clinical cure (resolution of infection symptoms) and microbiological cure (sterilization of CSF cultures).
Secondary Outcomes: Mortality rates and adverse drug events, such as nephrotoxicity, hepatotoxicity, chemical meningitis, or seizures.

开始日期2024-12-01

申办/合作机构

Ain Shams University

CTR20243990

/ Active, not recruitingN/A

评估注射用多黏菌素E甲磺酸钠单次和多次给药在中国健康成年受试者中的药代动力学研究。

研究受试制剂注射用多黏菌素E甲磺酸钠与参比制剂注射用多黏菌素E甲磺酸钠（Coly-Mycin® M）在健康成年受试者单次给药的药代动力学相似性。研究受试制剂注射用多黏菌素E甲磺酸钠在健康成年受试者多次给药的药代动力学特征和安全性

开始日期2024-10-28

申办/合作机构

齐鲁制药（海南）有限公司

100 项与多黏菌素E甲磺酸钠相关的临床结果

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100 项与多黏菌素E甲磺酸钠相关的转化医学

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100 项与多黏菌素E甲磺酸钠相关的专利（医药）

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1,242

项与多黏菌素E甲磺酸钠相关的文献（医药）

2024-12-01·Applied microbiology and biotechnology

Sensing chemical-induced DNA damage using CRISPR/Cas9-mediated gene-deletion yeast-reporter strains

Article

作者: Eki, Toshihiko ; Hirose, Yuu ; Matsunobu, Shogo ; Miura, Yuuki ; Yamamoto, Kosuke ; Tochikawa, Shintaro

Abstract:

Microorganism-based genotoxicity assessments are vital for evaluating potential chemical-induced DNA damage. In this study, we developed both chromosomally integrated and single-copy plasmid–based reporter assays in budding yeast using a RNR3 promoter–driven luciferase gene. These assays were designed to compare the response to genotoxic chemicals with a pre-established multicopy plasmid–based assay. Despite exhibiting the lowest luciferase activity, the chromosomally integrated reporter assay showed the highest fold induction (i.e., the ratio of luciferase activity in the presence and absence of the chemical) compared with the established plasmid-based assay. Using CRISPR/Cas9 technology, we generated mutants with single- or double-gene deletions, affecting major DNA repair pathways or cell permeability. This enabled us to evaluate reporter gene responses to genotoxicants in a single-copy plasmid–based assay. Elevated background activities were observed in several mutants, such as mag1Δ cells, even without exposure to chemicals. However, substantial luciferase induction was detected in single-deletion mutants following exposure to specific chemicals, including mag1Δ, mms2Δ, and rad59Δ cells treated with methyl methanesulfonate; rad59Δ cells exposed to camptothecin; and mms2Δ and rad10Δ cells treated with mitomycin C (MMC) and cisplatin (CDDP). Notably, mms2Δ/rad10Δ cells treated with MMC or CDDP exhibited significantly enhanced luciferase induction compared with the parent single-deletion mutants, suggesting that postreplication and for nucleotide excision repair processes predominantly contribute to repairing DNA crosslinks. Overall, our findings demonstrate the utility of yeast-based reporter assays employing strains with multiple-deletion mutations in DNA repair genes. These assays serve as valuable tools for investigating DNA repair mechanisms and assessing chemical-induced DNA damage.

Key points:

• Responses to genotoxic chemicals were investigated in three types of reporter yeast.• Yeast strains with single- and double-deletions of DNA repair genes were tested.• Two DNA repair pathways predominantly contributed to DNA crosslink repair in yeast.

2024-11-01·ANALYTICA CHIMICA ACTA

Ultrasensitive mass spectrometric quantitation of apurinic/apyrimidinic sites in genomic DNA of mammalian cell lines exposed to genotoxic reagents

Article

作者: Liu, Ying ; Xue, Chen-Yu ; Liu, Ya-Hong ; Zhang, Xin-Xiang ; Yu, Yue ; Zhou, Ying-Lin

The apurinic/apyrimidinic (AP) site is an important intermediate in the DNA base excision repair (BER) pathway, having the potential of being a biomarker for DNA damage. AP sites could lead to the stalling of polymerases, the misincorporation of bases and DNA strand breaks, which might affect physiological function of cells. However, the abundance of AP sites in genomic DNA is very low (less than 2 AP sites/10⁶ nts), which requires a sensitive and accurate method to meet its detection requirements. Here, we described an ultrasensitive quantification method based on a hydrazine-s-triazine reagent (i-Pr₂N) labeling for AP sites combining with high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). The limit of detection reached an ultralow level (40 amol), realizing the most sensitive MS-based quantification for the AP site. To guarantee the accuracy of the quantitative results, the labeling reaction was carried out directly on DNA strands instead of labeling after DNA enzymatic digestion to reduce artifacts that might be produced during the enzymatic process of DNA strands. And selective detection was realized by MS to avoid introducing the false-positive signals from other aldehyde species, which could also react with i-Pr₂N. Genomic DNA samples from different mammalian cell lines were successfully analyzed using this method. There were 0.4-0.8 AP sites per 10⁶ nucleotides, and the values would increase 16.1 and 2.75 times when cells were treated with genotoxic substances methyl methanesulfonate and 5-fluorouracil, respectively. This method has good potential in the analysis of a small number of cell samples and clinical samples, is expected to be useful for evaluating the damage level of DNA bases, the genotoxicity of compounds and the drug resistance of cancer cells, and provides a new tool for cell function research and clinical precise treatment.

2024-10-01·Lancet Respiratory Medicine

Inhaled colistimethate sodium in patients with bronchiectasis and Pseudomonas aeruginosa infection: results of PROMIS-I and PROMIS-II, two randomised, double-blind, placebo-controlled phase 3 trials assessing safety and efficacy over 12 months

Article

作者: Haworth, Charles S ; Shteinberg, Michal ; O'Donnell, Anne E ; Carroll, Kevin J ; Dimakou, Katerina ; Blasi, Francesco ; Winthrop, Kevin ; Sibila, Oriol ; Barker, Alan ; Morgan, Lucy C ; Pontenani, Federica ; Thomson, Rachel M ; Castellani, Paola ; Ringshausen, Felix C ; Chalmers, James D

BACKGROUND:

Chronic lung infection with Pseudomonas aeruginosa is associated with increased exacerbations and mortality in people with bronchiectasis. The PROMIS-I and PROMIS-II trials investigated the efficacy and safety of 12-months of inhaled colistimethate sodium delivered via the I-neb.

METHODS:

Two randomised, double-blind, placebo-controlled trials of twice per day colistimethate sodium versus placebo were conducted in patients with bronchiectasis with P aeruginosa and a history of at least two exacerbations requiring oral antibiotics or one requiring intravenous antibiotics in the previous year in hospitals in Argentina, Australia, Belgium, Canada, France, Germany, Greece, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Switzerland, the UK, and the USA. Randomisation was conducted through an interactive web response system and stratified by site and long term use of macrolides. Masking was achieved by providing colistimethate sodium and placebo in identical vials. After random assignment, study visits were scheduled for 1, 3, 6, 9, and 12 months (the end of the treatment period); and telephone calls were scheduled for 7 days after random assignment and 2 weeks after the end of treatment. The primary endpoint was the mean annual exacerbation rate. These trials are registered with EudraCT: number 2015-002743-33 (for PROMIS-I) and 2016-004558-13 (for PROMIS-II), and are now completed.

FINDINGS:

377 patients were randomly assigned in PROMIS-I (177 to colistimethate sodium and 200 to placebo; in the modified intention-to-treat population, 176 were in the colistimethate sodium group and 197 were in the placebo group) between June 6, 2017, and April 8, 2020. The annual exacerbation rate was 0·58 in the colistimethate sodium group versus 0·95 in the placebo group (rate ratio 0·61; 95% CI 0·46-0·82; p=0·0010). 287 patients were randomly assigned in PROMIS-II (152 were assigned to colistimethate sodium and 135 were assigned to placebo, in the modified intention-to-treat population), between Feb 12, 2018, and Oct 22, 2021. PROMIS-II was then prematurely terminated due to the effect of the COVID-19 pandemic. No significant difference was observed in the annual exacerbation rate between the colistimethate sodium and placebo groups (0·89 vs 0·89; rate ratio 1·00; 95% CI 0·75-1·35; p=0·98). No major safety issues were identified. The overall frequency of adverse events was 142 (81%) patients in the colistimethate sodium group versus 159 (81%) patients in the placebo group in PROMIS-I, and 123 (81%) patients versus 104 (77%) patients in PROMIS-II. There were no deaths related to study treatment.

INTERPRETATION:

The data from PROMIS-I suggest a clinically important benefit of colistimethate sodium delivered via the I-neb adaptive aerosol delivery system in patients with bronchiectasis and P aeruginosa infection. These results were not replicated in PROMIS-II, which was affected by the COVID-19 pandemic and prematurely terminated.

FUNDING:

Zambon.

项与多黏菌素E甲磺酸钠相关的新闻（医药）

2024-12-12

·GlobeNewswire-Health Care

Essential Pharma announces €900 million recapitalisation through a Gyrus Capital Continuation Vehicle led by AlpInvest and new strategic financing from Sixth Street

Essential Pharma announces €900 million recapitalisation through a Gyrus Capital Continuation Vehicle led by AlpInvest and new strategic financing from Sixth Street Provides significant resources to build on diversified portfolio of established and rare disease medicines Egham, UK – 12 December 2024 – Essential Pharma (“Essential” or “the Company”), an international specialty pharma group focused on ensuring that patients have access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, today announces the completion of a €900 million financing, through a Gyrus Capital single-asset Continuation Vehicle led by AlpInvest, a subsidiary of Carlyle Global Investment Solutions, and a new strategic financing facility with Sixth Street. Essential Pharma was acquired in 2019 by Gyrus Capital, who have supported the transformation of the Company into a global, high-growth specialty pharma group with significant development opportunities. The transaction will enable Essential to deploy additional capital to build on its diversified portfolio and late-stage pipeline across established and rare disease medicines. This will be achieved through its successful acquisition and development strategy under the leadership of CEO, Emma Johnson. This additional capital will support Essential’s mission to ensure access to essential medicines for patients across new and existing markets. Since her appointment in 2023, Emma has driven the Company’s expansion into rare diseases, with the addition of marketed product Colobreathe® and Hu14.18, an immunotherapy in late-stage clinical development for the treatment of high-risk neuroblastoma. Following the transaction, Lee Morley, appointed as Non-Executive Director to the Board in 2023, will assume the role of Chairman of Essential Pharma, succeeding Dr Patrick Vink. Lee has more than 30 years’ experience in the biopharmaceutical industry, with extensive knowledge of commercialisation, pricing, reimbursement and product launch strategy. He was a co-founder and CEO at EUSA Pharma before the company’s €750 million acquisition by Recordati (BIT: REC) in 2022. During his time at EUSA Pharma, he led the company’s transition from specialty pharma to oncology and rare disease, driving sales from €20 million to €150 million. Emma Johnson, CEO of Essential Pharma, commented: “This transaction provides us with substantial additional firepower, strengthening our ability to deliver essential medicines to patients who need them most. By moving into new geographical markets and building on our diversified portfolio and late-stage pipeline across our key therapeutic areas, we can expand our reach to help underserved patient populations across the globe. We are excited to continue our relationship with Gyrus Capital as we execute our strategy to become a leading, global specialty pharma group with a growing rare disease presence, where patient needs are often most acute. As we transition to our new ownership, I’d also like to thank Patrick for his significant contributions as Chairman and welcome Lee as he steps into the role.” Dr Robert Watson, Managing Partner at Gyrus Capital, said: “This is a landmark investment for Essential and for Gyrus Capital. We are delighted to partner with AlpInvest, Stepstone, Sixth Street and other significant private capital institutions, who believe in our shared vision of building an exceptional specialty pharma company, and bringing critical medical products to patients across the globe.” Sixth Street, a leading global investment firm with deep experience supporting biotech companies across all stages of growth, is providing a new strategic financing facility consisting of €300 million in structured equity and growth debt. Jeff Pootoolal, Partner at Sixth Street who will join the board of Essential Pharma, said: “Essential Pharma has assembled a leading team and platform in its pursuit of providing patients around the world with critical medicines. We are excited to support Emma and Essential’s leadership as they continue to execute and expand on their mission.” About Essential Pharma Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to clinically differentiated, niche, branded medicines across multiple therapeutic areas. The group has been an important and valued partner to healthcare providers for over 20 years by giving underserved patient populations access to medicines that otherwise might not be available, and addressing clinical unmet needs. Essential Pharma operates globally in more than 70 countries, supplying a portfolio of products with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare disease. The group’s growth strategy is centred on portfolio optimisation and a targeted M&A approach to acquire commercial and late-clinical stage assets in the four therapeutic areas of focus. It is a trusted partner to multiple pharma companies of all sizes, with a proven history of integrating assets and managing complex technology transfers seamlessly while ensuring continuous supply to patients. For more information, please visit essentialpharmagroup.com About Gyrus Capital Gyrus Capital is a European investment firm dedicated to transformational investments in the healthcare and sustainability sectors. Based in Geneva, Switzerland, Gyrus invests in businesses that address the structural needs of society and the environment and are positioned for long-term sustainable growth. The firm focuses on complex transactions, particularly corporate carve-outs in the €50 million to €500 million range. A renowned group of experienced partners and industry experts supports Gyrus’s active investment and value-creation approach, working closely with entrepreneurs and managers. To learn more, please visit www.gyruscapital.com About Sixth Street Sixth Street is a global investment firm with over $80 billion in assets under management and committed capital. Sixth Street uses its long-term flexible capital, data-enabled capabilities, and One Team culture to develop themes and offer solutions to companies across all stages of growth. Sixth Street Healthcare and Life Sciences finances the development and commercialization of innovative therapeutics and invests in healthcare technology companies across all stages of growth. Investments in the sector include Apellis Pharmaceuticals, Arrowhead Pharmaceuticals, Arsenal Biosciences, Biohaven, Blueprint Medicines, Caris Life Sciences, Chroma Medicine, ConcertAI, Datavant, Immunogen, Ironwood, and Mammoth Biosciences, among many others. Founded in 2009, Sixth Street has more than 650 team members including over 250 investment professionals operating around the world. For more information, visit www.sixthstreet.com, or follow Sixth Street on LinkedIn. CONTACTS Essential Pharma Emma Johnson, CEO Tel: +44(0)1784 477 167 Email: info@essentialpharmaceuticals.com ICR Healthcare Tracy Cheung/Sukaina Virji/Isabelle Abdou Tel: +44 (0) 20 3709 5700 Email: Essentialpharma@icrhealthcare.com

高管变更并购

2024-10-17

·shionogi.com

IDWeek 2024: Shionogi Presents Largest Global Real-World Evidence Study of Cefiderocol Demonstrating Strong Clinical Response Rates Across Seriously Ill Patients

Additional presentations show potent in vitro* activity for cefiderocol against emerging pathogens with limited treatment options, including those that are resistant to newer agents OSAKA, Japan, October 16, 2024 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announces new data at IDWeek 2024 from PROVE (Retrospective Cefiderocol Chart Review), the largest global real-world evidence study of Fetroja®/Fetcroja® (cefiderocol), an innovative siderophore cephalosporin, for the treatment of seriously ill adult patients with certain Gram-negative (GN) bacterial infections, the majority of which were carbapenem-resistant (CR). Please see below under About Cefiderocol the Full indications, and Important Safety Information of Fetroja in the U.S. PROVE is an international, multicenter, retrospective medical chart review study designed to describe the patient characteristics and clinical outcomes in patients treated with cefiderocol for GN bacterial infections in real-world settings between 2020 and 2024.1 Of the patients included in the analysis, 75.1% had a favorable clinical response to cefiderocol at the end of treatment (defined as resolution or improvement of signs and symptoms as judged by the physician, excluding deaths while on therapy).1 “Seriously ill patients with resistant Gram-negative bacterial infections are often difficult to treat. Although antibiotics are usually approved based on data from randomized controlled clinical trials, clinicians often rely on real-world evidence data to understand how antibiotics may perform in clinical settings,” said Cornelius (Neil) Clancy, MD, Professor of Medicine, University of Pittsburgh. “This real-world evidence from PROVE, the largest to date for cefiderocol, further support its use and importance as a treatment option for appropriate patients with carbapenem-resistant Gram-negative infections in clinical settings.” This analysis included 1,075 hospitalized patients, the majority (56.6%) of whom were in the intensive care unit and had a median age of 60 (range from 46-69 years).1 The majority (53.1%) of patients had respiratory tract infections (RTIs), 10.6% of patients had urinary tract infections (UTIs), and 10% of patients had bloodstream infections.1 Additionally, 74.6% of infections were resistant to carbapenems, antibiotic agents commonly used for treatment of severe bacterial infections.1,2 Of monomicrobial infections, the predominant pathogen was Pseudomonas aeruginosa (35.9%) followed by Acinetobacter baumannii (18.1%), and Enterobacterales (13.1%).1 Also a quarter of patients (25.2%) had polymicrobial infections, where an infection involved multiple concurrent Gram-negative pathogens.1 Clinical response rates were 71.6% in patients with RTI, 74.1% in patients with bloodstream infections and 91.2% in patients with UTIs.1 Overall, the rate of 30-day all-cause mortality (ACM) was 23.3%.1 There were 29 adverse drug reactions (ADRs) across 25 patients, including three serious ADRs.1 Of the 1,075 patients, 13 patients discontinued treatment with cefiderocol due to adverse drug reactions.1 Additional Studies Presented at IDWeek High Rates of Cross-Resistance Were Observed Among Beta-lactam/Beta-lactamase Inhibitors, But Not with Cefiderocol Data from two studies demonstrated the in vitro* activity of cefiderocol against multidrug-resistant Pseudomonas aeruginosa and Enterobacterales isolates that were non-susceptible to several contemporary beta-lactam/beta-lactamase inhibitor (BL/BLI) combinations.3,4 Cross-resistance, where bacteria are resistant to multiple distinct antibiotics within the same class, was observed at high rates between BL/BLI combinations, but not with cefiderocol.3,4,5 Cefiderocol Maintained Activity Against Highly Resistant Metallo-beta-lactamase Producing Bacteria Also at IDWeek, data will be presented from two studies that demonstrated the in vitro* activity of cefiderocol against bacteria that produce metallo-beta-lactamases (MBL), enzymes that can inactivate a majority of antibiotics.6,7 MBL-producing bacteria are difficult-to-treat and are becoming increasingly prevalent around the world, with almost no treatment options.8,9 These studies showed that cefiderocol was active against clinical isolates of Pseudomonas aeruginosa and Enterobacterales carrying MBL genes, including those that were nonsusceptible to carbapenems and BL/BLI combinations.6,7 “The findings of these studies provide insights on the dynamics where cross-resistance was observed among the beta-lactams and beta-lactamase inhibitor combinations where notably, cefiderocol demonstrated potent activity against isolates resistant to these inhibitor combinations. Additionally, cefiderocol showed activity against carbapenemase-producing Enterobacterales, especially isolates carrying metallo-beta-lactamases,” said Jose Alexander, MD, Director of Microbiology, Virology and Immunology at AdventHealth. “This information can lead us to more rational antimicrobial susceptibility testing and enhance rapid therapy decisions based on resistance markers and specific carbapenemase detection.” *In vitro activity does not necessarily correlate with clinical efficacy. About Shionogi in Infectious Disease Since 1953, Shionogi has been a leader in infectious disease discovery and commercialization. Our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Today, our global pipeline includes investigational agents developed to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus. As part of our commitment to addressing unmet medical needs, Shionogi is partnering with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi has a landmark license and technology transfer agreement for cefiderocol with Global Antibiotic Research and Development Partnership (GARDP) and a collaboration agreement with the Clinton Health Access Initiative (CHAI) to transform the landscape of access to antibiotics in many low-income countries, most lower-middle and upper middle-income countries, and select high-income countries. About Shionogi & Co. Ltd. Shionogi & Co., Ltd. is a leading global research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of "supplying the best possible medicine to protect the health and well-being of the patients we serve." Shionogi has discovered and developed novel antibiotics and medicines for HIV and influenza and currently markets medicines for infectious diseases and central nervous system disorders. Shionogi’s global pipeline includes research programs in infectious diseases, pain/CNS, metabolic disorders, rare diseases, oncology and stroke. For more information, visit https://www.shionogi.com/global/en/. Antimicrobial Resistance AMR is a major health burden that urgently needs to be addressed.10 Globally, in 2019, there were 1.27 million deaths attributable to bacterial AMR.10 Infections caused by carbapenem-resistant Gram-negative bacteria are often associated with a high mortality rate.11 If no action is taken, drug-resistant pathogens could cause more than 39 million deaths over the next 25 years.12 Shionogi’s Commitment to Fighting Antimicrobial Resistance Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continues to focus on research and development in anti-infectives. For more information, please refer to: https://www.shionogi.com/global/en/sustainability/amr.html. About Cefiderocol In Europe, cefiderocol is commercially available under the brand name Fetcroja® for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.13 In the U.S., cefiderocol is available under the brand name Fetroja® and is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTIs) caused by certain susceptible Gram-negative microorganisms.14 In Japan, cefiderocol is commercially available under the brand name Fetroja® and received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for various infections caused by strains resistant to carbapenem antibiotics among sensitive strains of Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia, and Acinetobacter species. U.S. INDICATIONS Fetroja® (cefiderocol) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. Fetroja is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens. USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Fetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja. WARNINGS AND PRECAUTIONS Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections An increase in 28-day all-cause mortality was observed in Fetroja-treated nosocomial pneumonia, bloodstream infections, or sepsis patients compared to those treated with best available therapy (BAT) in a clinical study (NCT02714595). Most BAT regimens contained colistin. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49. Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established. Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP. Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed with Fetroja. Before Fetroja is instituted, inquire about previous hypersensitivity to cephalosporins, penicillins, or other beta-lactam drugs. If an allergic reaction occurs, discontinue Fetroja. Clostridioides difficile-associated Diarrhea (CDAD) CDAD has been reported with nearly all systemic antibacterial agents, including Fetroja. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Seizures and Other Central Nervous System (CNS) Adverse Reactions Cephalosporins, including Fetroja, have been implicated in triggering CNS adverse reactions such as seizures. Encephalopathy, coma, asterixis, and neuromuscular excitability have been reported with cephalosporins, particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment. Adjust Fetroja dosing based on creatinine clearance. If focal tremors or seizures occur, evaluate patients to determine whether Fetroja should be discontinued. Development of Drug-Resistant Bacteria Prescribing Fetroja in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONS The most common adverse reactions occurring in ≥2% of patients receiving Fetroja in the cUTI trial were: diarrhea (4%), infusion site reactions (4%), constipation (3%), rash (3%), candidiasis (2%), cough (2%), elevations in liver tests (2%), headache (2%), hypokalemia (2%), nausea (2%), and vomiting (2%). The most common adverse reactions occurring in ≥4% of patients receiving Fetroja in the HABP/VABP trial were: elevations in liver tests (16%), hypokalemia (11%), diarrhea (9%), hypomagnesemia (5%), and atrial fibrillation (5%). Please click here for Full U.S. Prescribing Information for Fetroja® (cefiderocol). Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html U.S. Media: ShionogiCommunications@shionogi.com References: 1. Clancy C, et al. Real-World Effectiveness and Safety of Cefiderocol in the Treatment of Patients with Serious Gram-negative Bacterial Infections: Results of the PROVE Chart Review Study. Poster presented at IDWeek 2024. 2. Papp-Wallace KM, et al. Carbapenems: past, present, and future. Antimicrob Agents Chemother. 2011 Nov;55(11):4943-60. doi: 10.1128/AAC.00296-11. Epub 2011 Aug 22. PMID: 21859938; PMCID: PMC3195018. 3. Nguyen S, et al. Evaluation of Phenotypic Cross-Resistance between Cefiderocol and β-lactam/β-lactamase inhibitor combinations against Pseudomonas aeruginosa isolates from US Medical Centers. Poster presented at IDWeek 2024. 4. DeJonge B, et al. Cefiderocol retains in vitro activity against Enterobacterales non-susceptible to β-lactam-β-lactamase inhibitor combinations. Poster presented at IDWeek 2024. 5. Colclough A, et al. Patterns of cross-resistance and collateral sensitivity between clinical antibiotics and natural antimicrobials. Evol Appl. 2019 Jan 28;12(5):878-887. doi: 10.1111/eva.12762. PMID: 31080502; PMCID: PMC6503891. 6. Mendes RE, et al. Cefiderocol Activity against Pseudomonas aeruginosa Clinical Isolates Carrying Metallo-β-lactamase Genes in United States and European Hospitals (2020–2023). Poster presented at IDWeek 2024. 7. Mendes RE, et al. Cefiderocol Activity against Clinical Enterobacterales Isolates Carrying Metallo-β-lactamase Genes in United States and European Hospitals (2020–2023). Poster presented at IDWeek 2024. 8. Gharavi MJ, et al. Comprehensive study of antimicrobial susceptibility pattern and extended spectrum beta-lactamase (ESBL) prevalence in bacteria isolated from urine samples. Sci Rep 11, 578 (2021). https://doi.org/10.1038/s41598-020-79791-0 9. Boyd SE, et al. Metallo-β-Lactamases: Structure, Function, Epidemiology, Treatment Options, and the Development Pipeline. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00397-20. doi: 10.1128/AAC.00397-20. PMID: 32690645; PMCID: PMC7508574. 10. Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022; 399: 629–55. 11. Perez F, et al. ‘Carbapenem-Resistant Enterobacteriaceae: A Menace to our Most Vulnerable Patients’. Cleve Clin J Med. Apr 2013; 80(4): 225–33. 12. GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990-2021: a systematic analysis with forecasts to 2050. Lancet. 2024 Sep 28;404(10459):1199-1226. doi: 10.1016/S0140-6736(24)01867-1. Epub 2024 Sep 16. PMID: 39299261. 13. Fetcroja® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdf. Accessed September 10, 2024. 14. Fetroja® Prescribing information. Available at: https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf. Accessed September 10, 2024.

引进/卖出临床结果上市批准

2024-10-08

·BioSpace

Pfizer to Showcase Scientific Advancements in Respiratory and Other Infectious Diseases at IDWeek 2024

Presentations highlight momentum of Pfizer’s portfolio of infectious disease prevention and treatment options NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) will present data across its infectious disease portfolio at the upcoming IDWeek 2024 congress, held in Los Angeles from October 16-19, 2024. Data in 49 abstracts from company- and collaborator-led studies, will highlight the advances Pfizer is making in helping prevent and treat infectious diseases. “Pfizer is at the forefront of vaccine and therapeutic development in respiratory and infectious diseases,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. “IDWeek 2024 provides a crucial platform to showcase our innovative advancements and engage with the scientific community, as we work to effectively tackle the ongoing challenge posed by infectious diseases.” “As we approach another respiratory virus season, the importance of preventive vaccines and treatments to help keep us healthy is more apparent than ever,” said Luis Jodar, Ph.D., Chief Medical Affairs Officer, Vaccines/Antivirals, Pfizer. “We’re excited to present new, meaningful data that we hope will help further inform healthcare providers.” Pfizer will present research from its robust infectious disease portfolio, covering RSV, COVID-19, pneumococcal disease, Lyme disease, meningococcal disease, and serious bacterial and fungal infections. Details for Pfizer-sponsored, investigator-sponsored and collaborative research oral and poster presentations are below: Title/Abstract Number Presenting Name/Type Date/Time (PDT) Location ORAL & LATE-BREAKING PRESENTATIONS 580 - Pharmacokinetics (PK) and Safety of Nirmatrelvir/Ritonavir (NMV/r) in Non-Hospitalized Symptomatic Pediatric Patients Ages 6 Years and Older with COVID-19 Who Are at Increased Risk of Progression to Severe Disease (EPIC-Peds) Jacqueline Gerhart, PhD Oct 19 2:45 – 2:57 PM US PT 403 A 88 - Efficacy of Nirmatrelvir/Ritonavir in High-Risk Trial Participants With Prior SARS-CoV-2 Infection or Vaccination: A Pooled Analysis John M. McLaughlin, PhD Oct 17 10:42 – 10:54 AM US PT 411 165 - Real-world Abrysvo vaccine effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related severe acute respiratory infection (ARI) hospitalizations and emergency department (ED) visits—Kaiser Permanente of Southern California (KPSC), November 2023-April 2024 Sara Tartof, PhD, MPH, (KPSC)* Oct 17 1:45 – 3:00 PM US PT 403A 571 – Safety and Immunogenicity of Coadministered Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine With and Without Quadrivalent Influenza Vaccine in Adults ≥ 65 Years of Age Rahsan Erdem, MD Oct 19 1:45 – 2:03 PM US PT 408 A POSTER PRESENTATIONS COVID-19 P - 1194 - Comparison of COVID-19 Inpatient Burden in Hospitalized Children Age < 5years, by SARS-CoV-2 Variant Kathleen M. Andersen, PhD MSc Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1906 - Early COVID-19 and Severity of Subsequent Omicron Infection in Ontario, Canada Caroline Kassee, MPH (Sinai Health)* Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 1977 - Six-Month Trajectory of Symptoms of COVID-19 Fatigue by Age and BNT162b2 COVID-19 Vaccination Status: A Prospective Study Among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy Manuela Di Fusco, PhD Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2047 - Public Health Impact and Economic Value of an Additional Dose of Pfizer-BioNTech XBB.1.5-adapted COVID-19 Vaccine for Older Adults in the United States Alon Yehoshua, PharmD, MS Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2048 - COVID-19 XBB.1.5 vaccine uptake based on state vaccine registries compared to national survey data Angela Cook, MS Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2054 - Effectiveness of a Single COVID-19 mRNA Vaccine Dose in Individuals Previously Infected with SARS-CoV-2: A Systematic Review Hannah R. Volkman, PhD, MPH Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2060 - Effectiveness of BNT162b2 COVID-19 Vaccination Against Long COVID Among Older Adults: A Nationwide Study Manuela Di Fusco, PhD Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2062 - COVID-19 XBB.1.5-adapted vaccine uptake in immunocompromised individuals using tokenized state vaccine registries Matthew A. Brouillette, MPH Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2017 - Patient Reported Outcomes of Nirmatrelvir/Ritonavir Treatment for High-risk, Nonhospitalized Adults with Symptomatic COVID-19 Ashley S. Cha-Silva, PharmD, MS Oct 19 12:15 – 1:30 PM US PT Hall J & K Lyme Disease P - 599 - 6-Valent, OspA-Based VLA15 Lyme Disease Vaccine Candidate Against Lyme Borreliosis in a Healthy Pediatric and Adult Study Population: A Phase 2 Study Update James H. Stark, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1287 - Incidence of Symptomatic Lyme Borreliosis in Nine European Countries, 2018−2022 Frederick Angulo, DVM PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1291 - Racial disparities in Lyme disease among beneficiaries of US Medicaid and Medicare L. Hannah Gould, PhD, MS, MBA Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1293 - Healthcare Costs Associated with Lyme Disease in a U.S. Insured Population Holly Yu, MSPH Oct 18 12:15 – 1:30 PM US PT Hall J & K Meningococcal Disease P - 1299 - Epidemiology of Invasive Meningococcal Disease in the United States: Review of Recent Data and Identified Risk Factors Jessica Presa, MD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1304 - Public Health Impact of changes to Meningococcal vaccination platform in the United States Katharina Schley, Dr. rer pol. Oct 18 12:15 – 1:30 PM US PT Hall J & K Pneumococcal disease P - 8 - Assessment of 13-valent pneumococcal conjugate vaccine effectiveness among people living with HIV in the United States Amanda C. Miles, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 628 - Real-world impact of pneumococcal conjugate vaccines on vaccine serotypes and cross-reacting non-vaccine serotypes Kevin Apodaca, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 629 - The health and economic impact of the PCV15 and PCV20 priming series during the first year of life in the US Mark Rozenbaum, PhD, M.B.A Oct 17 12:15 – 1:30 PM US PT Hall J & K Respiratory Syncytial Virus (RSV) P - 673 - Respiratory Syncytial Virus (RSV) Hospitalizations During Off-Season Months Among Infants in US Amy W. Law, PharmD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 674 - The Economic Burden of Infant RSV Among US Caregivers Amy W. Law, PharmD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 40 - Impact of case and control selection on influenza vaccine effectiveness (VE) among adults aged 40 years and older hospitalized with acute respiratory illness (ARI) during 2022-2023 using a test negative design (TND): secondary analysis of the North America Multi-Specimen Study Negar Aliabadi, MD, MS Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1204 - Hospitalizations Associated with Respiratory Syncytial Virus (RSV) Illness Among Children and Adolescents in Ontario, Canada Sazini Nzula, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1205 - Impact of the COVID-19 Pandemic on Hospitalizations Associated with Respiratory Syncytial Virus (RSV) Illness Among Children and Adolescents in Ontario, Canada Sazini Nzula, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 677 - Estimation of Respiratory Syncytial Virus-Attributable Hospitalizations Among Older Adults in Japan between 2015 and 2018: An Administrative Health Claims Database Analysis Asuka Yoshida, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 680 - Estimated Respiratory Syncytial Virus (RSV)-Related Hospitalizations and Deaths Among Adults in Norway between 2010–2019 Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 682 - The Risk of Cardiorespiratory Events for Up to 180 days Following Respiratory Syncytial Virus (RSV) Infection Hospitalization: A Self-Controlled Case Series Analysis Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P – 683 – Estimation of RSV-Attributable Cardiovascular and Respiratory Hospitalizations in Adults in Germany, Between 2015-2019 Caroline Beese Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 604 - Preliminary real-world Abrysvo vaccine effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related lower respiratory tract disease (LRTD) hospitalizations and emergency department (ED) visits—Kaiser Permanente of Southern California (KPSC) November 2023-April 2024 Negar Aliabadi, MD, MS Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 53 - Trends in Co-administration of Adult Vaccinations in the US Retail Pharmacy Setting Reiko Sato, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 603 - Potential Public Health Impact of Respiratory Syncytial Virus (RSV) Vaccines for Prevention of RSV Among Older Adults in the United States Reiko Sato, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 600 - Efficacy Of a Bivalent RSVpreF Vaccine in Older Adults Across a Second RSV Season John Woodside, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 596 - Immunobridging Demonstrating Effectiveness of the Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Adults 18-59 Years of Age at High Risk of Severe RSV Disease in a Phase 3 Trial: The C3671023 MONeT Study Results Elliot N. DeHaan, MD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 681 - Estimated Incidence of Respiratory Syncytial Virus (RSV)-Related Hospitalizations for Acute Respiratory Infections (ARIs), including Community Acquired Pneumonia (CAP), in Adults in Germany Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 605 - Bivalent RSV Prefusion F-Based Subunit Vaccine Generates High and Durable Neutralizing Titers Across an Entire RSV Season Among Older Adults Tarek Mikati, MD, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 595 - Public Health Impact of RSVpreF Vaccination on Older Adult Disease Outcomes Daniel Eiras, MD, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 21 - Comparison of Three RSV Vaccine Lower Respiratory Tract Disease Primary Endpoint Definitions for Adult Vaccine Sarah E. Williams, MD. MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 2357 - Respiratory Syncytial Virus (RSV) Disease Burden Among Adults in Primary Care Settings in High-Income Countries: A Systematic Review and Modelling Study You Li; multiple Pfizer co-authors Oct 19 12:15 – 1:30 PM US PT Hall J & K Aztreonam-Avibactam P - 105 - Aztreonam-Avibactam Compared with Adjunctive Colistin Combined with Meropenem for the Treatment of Serious Gram-Negative Bacterial Infections: Subgroup Analysis of the Phase 3 REVISIT Study Heidi Leister-Tebbe, BSN Oct 17 12:15-1:30 PM US PT Hall J & K P - 1080 Aztreonam-Avibactam Activity Against Gram-negative Bacteria Isolated From Patients with Pneumonia from Europe, Asia, and Latin America (2021–2023) Helio S. Sader, MD, PhD, FIDSA Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1256 - Pharmacokinetic/Pharmacodynamic (PK/PD) Target Attainment Analyses for Aztreonam-Avibactam Dosing Regimens Susan Raber*, PharmD, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1508 - In Vitro Activity of Aztreonam-Avibactam Against Enterobacterales Isolates Producing Multiple β-lactamases Collected Globally as a Part of the ATLAS Global Surveillance Program From 2018-2022 Mark Estabrook*, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1509 - In Vitro Activity of Aztreonam-Avibactam Against Enterobacterales Isolated From Pediatric and Adult Patients Collected During the ATLAS Global Surveillance Program, 2018-2022 Mark Estabrook*, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K Isavuconazole P - 1168 - Activity of Isavuconazole and Comparator Agents Against Pediatric Fungal Isolates Collected from 2017–2023 in a Global Surveillance Program Marisa Winkler, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K Ceftazidime-Avibactam P- 1506 - In Vitro Activity of Ceftazidime-Avibactam and Comparator Agents Against Pseudomonas aeruginosa Collected from Patients with Presumed Hospital- and Community-Acquired Respiratory Tract Infections as a Part of the ATLAS Global Surveillance Program 2018-2022 Mark Estabrook, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P- 1507 - In Vitro Activity of Ceftazidime-Avibactam Against Enterobacterales Isolates Producing Multiple β-lactamases Collected Globally as a Part of the ATLAS Global Surveillance Program from 2018-2022 Mark Estabrook, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K * =multiple Pfizer co-authors Prescribing Information for Pfizer Medicines Please see full Prescribing Information for ABRYSVO ® (Respiratory Syncytial Virus Vaccine) or visit and . Please see full Prescribing Information for COMIRNATY ® (COVID-19 Vaccine, mRNA) or visit . Please see full Prescribing Information for CRESEMBA ® (Isavuconazonium Sulfate) or visit Please see full Prescribing Information for PAXLOVID TM (Nirmatrelvir and Ritonavir) or visit . Please see full Prescribing Information for PREVNAR 20 TM (Pneumococcal 20-valent Conjugate Vaccine) or visit . Please see full Prescribing Information for PREVNAR 13 ® (Pneumococcal 13-valent Conjugate Vaccine). Please see full Prescribing Information for ZAFICEFTA ® (Ceftazidime-Avibactam). About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer . DISCLOSURE NOTICE: The information contained in this release is as of October 8, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s infectious disease pipeline, in-line products and product candidates, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s infectious disease products and product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and . Contacts Media Contact: PfizerMediaRelations@Pfizer.com +1 (212) 733-1226 Investor Contact: IR@Pfizer.com +1 (212) 733-4848

疫苗临床3期临床2期临床结果

100 项与多黏菌素E甲磺酸钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02049	多黏菌素E甲磺酸钠	J01XB01 A07AA10	DB01111

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
革兰氏阴性菌感染	中国	正大天晴药业集团股份有限公司	2021-10-11
肺部感染	欧盟	Essential Pharma Ltd.	2012-02-13
肺部感染	冰岛	Essential Pharma Ltd.	2012-02-13
肺部感染	列支敦士登	Essential Pharma Ltd.	2012-02-13
肺部感染	挪威	Essential Pharma Ltd.	2012-02-13
囊性纤维化	澳大利亚	Phebra Pty Ltd.	2011-02-02
铜绿假单胞菌感染	澳大利亚	Phebra Pty Ltd.	2011-02-02
感染	美国	Endo Operations Ltd.	1970-06-04
感染性肠炎	日本	Sun Pharma Japan Ltd.	1960-11-22

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性肺疾病	临床3期	美国	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	阿根廷	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	澳大利亚	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	加拿大	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	法国	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	德国	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	希腊	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	以色列	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	意大利	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	新西兰	Zambon SpA	2018-01-29

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03460704 (PROMIS-II, CTgov)	临床3期	非囊性支气管扩张 \| 慢性肺疾病	287	CMS (CMS (Colistimethate Sodium))	蓋願鹹鹽廠網膚鹹壓淵(鬱積構構鑰鑰積網齋繭) = 窪廠窪網製簾顧鹽廠選淵鹹繭鹽窪積糧齋選蓋 (衊顧築獵醖襯糧獵鹹艱, 艱醖艱憲製積餘衊餘製 ~ 製製憲範壓夢膚遞鬱鏇)	-	2023-12-29
				Placebo (Placebo)	蓋願鹹鹽廠網膚鹹壓淵(鬱積構構鑰鑰積網齋繭) = 築壓願製鑰選襯襯構簾淵鹹繭鹽窪積糧齋選蓋 (衊顧築獵醖襯糧獵鹹艱, 築獵鏇繭範繭範觸築觸 ~ 製築鏇獵網鑰壓餘獵醖)
NCT03093974 (PROMIS-I, CTgov)	临床3期	非囊性支气管扩张 \| 感染	377	Placebo	餘艱願膚獵簾獵積選廠(壓廠範蓋願餘膚壓鹽築) = 鑰範壓築鏇齋繭壓鏇願遞夢鹽製廠構鹽醖鹽膚 (鹽遞積製獵鹽壓鹽醖鹽, 築遞蓋蓋壓獵選襯範繭 ~ 鑰鑰願顧範鹽廠醖遞鹽)	-	2023-11-15
NCT03093974 (PROMIS-I, Corporate Publications) 人工标引	临床3期	非囊性支气管扩张	377	Colistimethate Sodium	蓋鑰願廠網繭鹽顧壓蓋(壓壓廠糧願網製簾繭鹽) = 積淵餘構積製觸餘廠範範繭構鹹製鹹鬱觸範蓋 (積廠鏇顧壓鑰鏇鏇獵構 )	积极	2021-09-08
				Placebo	蓋鑰願廠網繭鹽顧壓蓋(壓壓廠糧願網製簾繭鹽) = 積鹹構鹽簾製齋選鑰鹹範繭構鹹製鹹鬱觸範蓋 (積廠鏇顧壓鑰鏇鏇獵構 )
PROMIS-I (ERS2021)	N/A	支气管扩张 Pseudomonas aeruginosa	377	Colistimethate sodium I-neb	製鹹範淵網夢壓範鹽壓(繭衊願窪網壓構獵製艱) = 繭膚製廠廠獵夢範鏇齋鏇鑰窪夢鏇願鏇積鬱簾 (壓衊範繭窪繭糧築範鬱 )	积极	2021-09-05
				Placebo	製鹹範淵網夢壓範鹽壓(繭衊願窪網壓構獵製艱) = 壓鏇鹽觸膚選鹹觸鹽網鏇鑰窪夢鏇願鏇積鬱簾 (壓衊範繭窪繭糧築範鬱 )
OPEN STUDY OF THE ASSOCIATIONCOLIMYCINE / GENTAMYCIN (UEGW)	N/A	盲袢综合征	99	COLIGENTA (COLIMYCINE / GENTAMYCINE)	鑰顧獵鏇壓鹹糧積衊繭(製範壓鹹廠鹽憲構廠憲) = 餘鏇簾製鏇鬱願醖窪積夢鬱壓鹽糧醖積鏇壓願 (鬱願窪遞構艱觸鏇顧壓 ) 更多	积极	2019-10-01
ASN2017	N/A	急性肾损伤	126	Colistimethate Sodium	壓窪範艱糧蓋蓋構夢選(獵獵廠蓋鹽構獵蓋憲繭) = 範願繭獵選構壓夢夢鏇廠糧築觸窪構淵構淵憲 (蓋積醖襯築選積餘遞選 )	积极	2017-10-31
ERS2016	N/A	-	-	Colistimethate sodium reconstituted with deionized water	艱觸膚餘築鏇艱願壓窪(鑰選積鬱襯築夢獵壓衊) = 夢觸餘鏇鑰選淵觸憲獵窪膚繭鹹簾憲鏇選鹹壓 (築淵壓鹽艱艱簾範廠製, 97 ~ 101)	-	2016-09-01
				Colistimethate sodium reconstituted with 0.9% saline	艱觸膚餘築鏇艱願壓窪(鑰選積鬱襯築夢獵壓衊) = 構鏇積糧襯鬱遞獵繭齋窪膚繭鹹簾憲鏇選鹹壓 (築淵壓鹽艱艱簾範廠製, 97 ~ 101)
ERS2015	N/A	谷氨酸单钠敏感	106	Nebulized colistimethate sodium (Promixin)	鏇願餘鑰鏇艱積製醖顧(遞顧顧築選齋積鏇襯壓) = 醖簾糧觸廠鑰壓遞網選鏇窪願獵顧製鏇繭夢膚 (鑰觸淵鹹衊齋淵鏇鏇窪 )	-	2015-09-01
ISRCTN49790596 (Pubmed \| Am J Respir Crit Care Med)	N/A	铜绿假单胞菌感染	-	Colistin	鹹願蓋餘遞顧窪簾糧鹽(觸餘憲餘鬱窪膚窪觸壓) = 鹹齋繭廠鏇遞蓋廠壓構鑰構鑰範鹽淵廠繭夢築 (膚鹹廠築夢網廠醖鏇夢 )	积极	2014-04-15
				Placebo	鹹願蓋餘遞顧窪簾糧鹽(觸餘憲餘鬱窪膚窪觸壓) = 衊鹹醖鏇製鹹製遞餘積鑰構鑰範鹽淵廠繭夢築 (膚鹹廠築夢網廠醖鏇夢 )
AAAAI2014	N/A	-	-	Colistimethate Sodium (More aggressive desensitization protocol)	獵鬱餘願鏇積鹹獵鏇遞(壓鬱鬱網廠鹽憲繭獵窪) = 鹽壓蓋獵鑰餘淵鹹鏇遞製衊積憲夢艱繭廠築衊 (膚簾鑰淵鏇簾窪襯糧膚 )	-	2014-02-01