A randomized controlled trial to compare safety and efficacy of inhalational long acting ß2 agonist Vilanterol with fluticasone furoate against Salmeterol with fluticasone furoate in adult patients with reversible obstructive airway disease. - NIL

开始日期2024-05-06

申办/合作机构-

CTRI/2024/03/064848

/ Not yet recruiting临床3期IIT

A comparative study of Vilanterol/Fluticasone furoate with Formoterol/Budesonide in the management of stable bronchial asthma - nil

开始日期2024-04-10

申办/合作机构-

CTR20233844

/ Active, not recruitingN/A

糠酸氟替卡松维兰特罗吸入粉雾剂在健康人空腹状态下的生物等效性试验

主要研究目的：以Glaxo Wellcome Production公司生产的糠酸氟替卡松维兰特罗吸入粉雾剂（RELVAR/ELLIPTA）为参比制剂，评价正大天晴药业集团股份有限公司研制的糠酸氟替卡松维兰特罗吸入粉雾剂在空腹状态下的生物等效性（BE）。次要研究目的：观察受试制剂糠酸氟替卡松维兰特罗吸入粉雾剂和参比制剂RELVAR/ELLIPTA在健康试验参与者中的安全性。

开始日期2023-12-03

申办/合作机构

连云港润众制药有限公司

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100 项与糠酸氟替卡松/三苯乙酸维兰特罗相关的临床结果

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100 项与糠酸氟替卡松/三苯乙酸维兰特罗相关的转化医学

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100 项与糠酸氟替卡松/三苯乙酸维兰特罗相关的专利（医药）

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项与糠酸氟替卡松/三苯乙酸维兰特罗相关的文献（医药）

2025-01-01·RESPIRATORY MEDICINE

Particularities of deposition of two ICS-LABA fixed dose combination dry powder aerosol drugs in the airways of COPD patients

Article

作者: Gálffy, Gabriella ; Kis, Erika ; Ilyés, Norbert ; Sánta, Balázs ; Horváth, Alpár ; Böcskei, Renáta Marietta ; Farkas, Árpád ; Kovács, Tamás ; Bártfai, Zoltán ; Réti, Izolda ; Havadtői, Botond

The aim of this study was to analyse the effect of breathing parameters, age, gender and disease status on the lung doses of the two ICS + LABA fixed combination dry powder drugs. Breathing parameters of 113 COPD patients were measured while inhaling through emptied NEXThaler® and Ellipta® inhalers and the corresponding lung doses were calculated. Lung dose of Foster® NEXThaler® was superior to the lung dose of Relvar® Ellipta® in around 85 % of the patients. The average value of the ratio of bronchiolar to bronchial deposition fractions was 5.0 for Foster® NEXThaler® and 2.6 for Relvar® Ellipta®. Lung dose was sensitive to the inhalation parameters, such as peak inhalation flow, inhaled volume and breath-hold time. For both studied drugs the dose to the lungs was relatively high for moderate PIF values, but it declined for low (<35 L/min) and high (>95 L/min) PIFs. The lung dose increased by the increase of the inhaled volume, but saturated over 1.0 L of inhaled air. Longer breath-hold time led to higher lung deposition, but the dependence was drug-specific. FEV₁ (%) and FEV₁/FVC (%) did not influence the lung dose significantly (p = 0.05). Exacerbating patients had lower lung doses (28.8 ± 5.8 % for Foster® NEXThaler® and 23.7 ± 3.8 % for Relvar® Ellipta®) than their non-exacerbating counterparts (33.7 ± 6.1 % for Foster® NEXThaler® and for 24.9 ± 3.9 % for Relvar® Ellipta®). The exact clinical consequences of the differences between the deposition distributions of the two drugs could be assessed only by systematic clinical trials.

2023-12-01·International journal of pharmaceutics: X

The effect of lung emptying before the inhalation of aerosol drugs on drug deposition in the respiratory system

Article

作者: Kugler, Szilvia ; Farkas, Árpád ; Tomisa, Gábor ; Szénási, Georgina ; Nagy, Attila ; Füri, Péter ; Horváth, Alpár ; Varga, János

The amount of drug depositing in the airways depends, among others, on the inhalation manoeuvre and breathing parameters. The objective of this study was to quantify the effect of lung emptying before the inhalation of drugs on the lung doses. Thirty healthy adults were recruited. Their breathing profiles were recorded while inhaling through six different emptied DPI devices without breathe-out and after comfortable or forced exhalation. The corresponding emitted doses and aerosol size distributions were derived from the literature. The Stochastic Lung Model was used to estimate the deposited doses. In general, forceful exhalation caused increased flow rate and inhaled air volume. Increased flow rate led to the increase of the average lung dose for drugs with positive lung dose-flow rate correlation (e.g. Symbicort®: relative increase of 6.7%, Bufomix®: relative increase of 9.2%). For drugs with negative correlation of lung dose with flow rate (all the studied drugs except the above two) lung emptying caused increased (Foster® by 2.7%), almost unchanged (Seebri®, Relvar®, Bretaris®) and also decreased (Onbrez® by 6.6%) average lung dose. It is worth noting that there were significant inter-individual differences, and lung dose of each drug could be increased by a number of subjects. In conclusion, the change of lung dose depends on the degree of lung emptying, but it is also inhaler and drug specific. Forceful exhalation can help in increasing the lung dose only if the above specificities are taken into account.

2023-10-01·Drug safety

Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea.

Article

作者: Cho, Eun-Yeong ; Jang, Seung Hun ; Cho, Jung-Eun ; Hwang, Ki-Eun

BACKGROUND AND OBJECTIVE:

Fluticasone furoate/vilanterol (FF/VI; RELVAR ELLIPTA) is approved in Korea for patients with asthma or chronic obstructive pulmonary disease (COPD). This study evaluated the effectiveness and safety of FF/VI in Korean patients with asthma and/or COPD over a 6-year period.

METHODS:

This was an open-label, multicentre, observational, post-marketing surveillance study in patients newly treated with FF/VI (100 or 200 μg/25 μg once daily). Safety endpoints were the incidence of adverse events (AEs), including unexpected AEs/adverse drug reactions (ADRs) and serious AEs/ADRs. Effectiveness was assessed after 24 weeks by Global Physician Assessment (logistic regression) and forced expiratory volume in 1 s (FEV₁; paired t-tests).

RESULTS:

Of the 3426 patients enrolled across 45 hospitals between July 2014 and June 2020, 3216 were included in the safety analysis (50.5% female; mean age ± standard deviation [SD]: 58.6 ± 16.3 years). Overall incidence of AEs was 30.9% (n = 992); 4.1% (n = 132) were ADRs. Serious AEs were reported in 4.1% (n = 132) of patients; 0.1% (n = 4) were ADRs. Of 1543 patients analysed for symptomatic improvement, 89.2% (n = 1377) improved, 9.4% (n = 145) were unchanged, and 1.4% (n = 21) worsened. Mean FEV₁ (difference ± SD) increased significantly in patients with asthma (0.09 ± 0.29 L; p < 0.0001), COPD (0.11 ± 0.24 L; p = 0.0011), or both (0.05 ± 0.18 L; p = 0.0399), indicating improved lung function.

CONCLUSION:

In this real-world study, FF/VI administered to Korean patients was well tolerated and effective for the treatment of asthma and COPD. These results were consistent with other studies in Asian and global populations.

项与糠酸氟替卡松/三苯乙酸维兰特罗相关的新闻（医药）

2025-03-04

·Firstwordpharma

ICER says GSK's inhaled COPD drugs offer dosing edge over generics

Having recently been selected for the second round of US drug price talks, GSK's chronic obstructive pulmonary disease (COPD) treatments Trelegy Ellipta and Breo Ellipta have received a boost from the Institute for Clinical and Economic Review (ICER) ahead of the start of negotiations.An analysis from the cost watchdog determined that GSK's two inhaled therapies "offer the advantage of requiring only one puff once a day" for the maintenance treatment of COPD. In contrast, comparator generics to Trelegy Ellipta require two inhalers administered twice daily, while for Breo Ellipta, they generally require at least one inhaler twice daily. According to ICER, observational data suggest that patients are more adherent to once-daily therapy, which may lead to fewer COPD exacerbations. The watchdog concluded that Trelegy Ellipta has comparable or incremental net health benefits compared with other generic triple therapies, with the same for Breo Ellipta versus generic inhaled corticosteroid/long-acting beta-agonist dual therapies administered twice daily.Breo Ellipta combines the inhaled corticosteroid fluticasone furoate with the long-acting beta-agonist vilanterol, while Trelegy Ellipta adds the long-acting muscarinic antagonist umeclidinium to this dual regimen. A recent analysis indicated that total Part D Medicare prescription drug costs for Trelegy Ellipta between November 1, 2023, and October 31, 2024, were $5.1 billion, and $1.4 billion for Breo Ellipta.ICER chief executive Sarah Emond noted that the new analysis "will be one of many inputs" considered by the Centers for Medicare & Medicaid Services in negotiations with GSK. "We hope that it will help them as they continue to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people."

2025-01-23

·摩熵医药

心血管与COPD治疗重磅药物专利即将到期，正大天晴或成仿制头马！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。近年来，随着我国药品专利链接制度的不断完善，原研药与仿制药之间的平衡成为医药产业发展的关键。一方面，延长创新药专利保护期有助于激励药物创新；另一方面，鼓励仿制药企业通过专利挑战和规避，提高药品可及性，促进产业高质量发展。在此背景下，摩熵咨询发布的《专利即将到期五大重磅小分子药品，国内仿制药“战况”几何》研究报告，对五款即将专利到期的重磅药品进行了盘点和分析。本文将重点介绍其中两款药品：ENTRESTO®（诺欣妥）、TRELEGYELLIPTA®（全再乐），并分析其国内仿制药研发格局和专利挑战现状，为业界提供一份宝贵的战略参考。一、 ENTRESTO®（诺欣妥）：心血管领域的创新药 1.ENTRESTO®药物简介及重要交易事件 ENTRESTO®（诺欣妥），通用名为沙库巴曲缬沙坦钠片，活性成分为沙库巴曲和缬沙坦三钠半五水合物。原研企业为Novartis（诺华），首次于2015年7月在美国获批上市，是全球首个血管紧张素受体脑啡肽酶抑制剂（ARNI）类药物，用于治疗心力衰竭和原发性高血压。摩熵医药数据库显示，该药物于2017年7月26日在中国获批进口。沙库巴曲缬沙坦钠片研发状态及历程图片来源：摩熵医药全球药物研发数据库沙库巴曲缬沙坦钠片含有脑啡肽酶抑制剂沙库巴曲和血管紧张素受体阻滞剂缬沙坦，可通过LBQ657（前体药物沙库巴曲的活性代谢物）抑制脑啡肽酶（中性内肽酶；NEP），并通过缬沙坦阻断血管紧张素II1型(AT)受体。自上市以来，诺华已将沙库巴曲缬沙坦钠片分销权授予多家公司，其重要交易事件包括：2016年11月，诺华将其在西班牙的分销权授予LaboratoriosFarmaceuticosRoviSA；2020年2月，诺华与日本大冢制药达成商业化许可协议（原研沙库巴曲缬沙坦钠片在日本的原研代理公司为日本大冢制药）；2022年4月，DrReddy‘sLaboratories从诺华处购买获得原研沙库巴曲缬沙坦钠片在印度的商业权益。 2.临床应用与指南推荐：心衰和原发性高血压治疗药物沙库巴曲缬沙坦钠，是国内外多个指南一致推荐的心衰和原发性高血压治疗药物。从临床研究成果来看，在心力衰竭治疗方面，2016年欧洲心脏病学会以及2017年美国心脏病学会/美国心脏协会更新的心衰指南，均把沙库巴曲缬沙坦钠作为HFrEF的Ⅰ类推荐，而且《中国心力衰竭诊断和治疗指南2018》《慢性心力衰竭基层诊疗指南（2019年）》和《基层心血管病综合管理实践指南2020》也都明确推荐了ARNI（沙库巴曲缬沙坦钠）在HFrEF患者中的应用。 2021年1月，美国心脏病学会更新的优化心衰治疗专家共识中，建议HFrEF患者在不使用ACEI/ARB预处理的情况下，可优先使用该药。此外，2021年2月，FDA批准了沙库巴曲缬沙坦钠扩大适应证的申请，允许其用于降低成年人慢性心衰患者的心血管死亡和心衰住院风险，涵盖HFpEF患者。在高血压治疗领域，2020年国际高血压学会发布的全球高血压实践指南指出，沙库巴曲缬沙坦钠也适用于高血压人群，2021年2月发表的《沙库巴曲缬沙坦钠在高血压患者中临床应用中国专家建议》更是建议将其用于原发性高血压病患者的降压治疗，尤其是老年高血压、盐敏感性高血压、高血压合并心衰、高血压合并左心室肥厚、高血压合并慢性肾脏病（1~3期）和高血压合并肥胖的患者。沙库巴曲缬沙坦钠国内外相关指南推荐意见此外，还有充分的循证证据支持沙库巴曲缬沙坦钠的降血压效果以及靶器官保护作用。沙库巴曲缬沙坦钠部分降压询证证据列表 3.市场表现：心血管领域突破性创新药，原研产品全球销售额近90亿美元作为全球首款心血管治疗领域的突破性创新药，近年来原研沙库巴曲缬沙坦钠片全球市场销售额高速增长，2023年达88.5亿美元，国内市场整体也呈上升趋势，2023年总销售额超3亿美元，但在全球市场中占比较小，约4.2%。数据来源：摩熵医药销售数据库沙库巴曲缬沙坦钠已获批的适应症包括心力衰竭、原发性高血压和高血压病，其中心力衰竭在中、美、日、欧均已获批，高血压在中国和日本已获批。摩熵医药数据库显示，截至2024年10月，除已获批的适应症外，沙库巴曲缬沙坦钠还有其他心血管疾病领域适应症在研发中，其中心肌梗死在中国和美国已进入III期临床阶段，中国的III期临床试验已完成。沙库巴曲缬沙坦钠片全球主流国家/地区研发现状图片来源：摩熵咨询《专利即将到期五大重磅小分子药品，国内仿制药“战况”几何》 4.原研专利情况及挑战历程：组合物专利全部无效，晶型专利可能延期原研沙库巴曲缬沙坦钠片在中国的核心专利包括组合物专利（公开号CN102091330B）和晶型专利（公开号CN101098689B（母案）CN102702119B（分案）），组合物专利早在2018年1月已宣告全部无效，晶型专利部分无效，有效部分预计2026年11月8日到期。沙库巴曲缬沙坦钠片原研中美核心专利信息一览沙库巴曲缬沙坦钠片原研化合物/组合物专利已于2018年1月3日被宣告全部无效，尽管原研公司诺华对此判决持有异议并先后上诉至北京知识产权法院及最高人民法院，但最终在2021年6月30日的二审判决中维持了原判，确认该专利全部无效。沙库巴曲缬沙坦钠片原研中国核心专利无效挑战历程与此同时，沙库巴曲缬沙坦钠片原研2.5水合物晶型专利也接连遭受了来自深圳信立泰药业、石药集团欧意药业及南京正大天晴制药的无效挑战，并于2021年7月2日被宣告部分无效。此外，南京一心和医药自主研发出了沙库巴曲缬沙坦钠新晶型，该晶型为3水合物，已做到与原研2.5水合物等效，考虑到可能仍有侵权风险，于2023年9月28日，南京一心和医药对原研0-3水合物晶型专利发起了无效挑战，2024年8月8日该专利被宣告部分无效，2024年9月3日无效宣告结案。值得一提的是，沙库巴曲缬沙坦钠片原研晶型专利经历诸多无效挑战至今未能被全部无效，有效部分原本预计2026年11月8日到期，但诺华已提交专利期限补偿请求，目前已进入审查，释放出专利保护期可能延长的信号。 5.仿制药研发与竞争情况：仿制研发热潮兴起，国内50+家企业群雄逐鹿专利挑战与仿制研发热潮兴起，原研公司诺华采取和解的方式维护专利权益。沙库巴曲缬沙坦钠片的问世在心血管领域开辟了一片新的蓝海，众多仿制企业对这块“肥肉”虎视眈眈，开始着手研发仿制药品，实力雄厚的企业纷纷对原研专利发起无效挑战，意图抢占首仿地位，其他众多企业也趁势入局，引发了仿制热潮。摩熵医药中国药品审评数据库显示，截至2024年9月20日，已有13家仿制药企业获得批文，21家企业正在申报注册中，另外还有15家企业正在开展BE试验。经统计，目前已获得仿制药批文的13家企业中，有4家对原研晶型专利明确登记了3类声明，有1家（浙江昂利康制药）登记了4.2类，1家（江苏华瀚医药）登记了2类，有7家企业未登记。值得注意的是江苏华瀚获得了原研专利实施许可，可实现提前上市销售；正大天晴获得原研0-3水合物晶型专利实施许可，但推测仍需等待2.5水合物晶型专利过期后才能上市销售。申报注册的21家企业中20家登记了3类声明，1家（江苏利泰尔药业）登记了4.2类声明，经查询，江苏利泰尔药业与自主研发新晶型的南京一心和医药同属方生和医药的子公司。面对仿制药企的专利挑战和仿制热潮，诺华与部分仿制药企达成和解协议，以避免专利悬崖，维持专利权益，降低市场损失。沙库巴曲缬沙坦钠片仿制药中国批准文详情沙库巴曲缬沙坦钠片中国新申报注册详情（想查看表格详细内容，请前往摩熵咨询官网获取报告全文）二、 TRELEGY ELLIPTA®（全再乐）：新一代COPD和哮喘三联疗法 1.TRELEGY ELLIPTA®药物简介及重要交易事件 TRELEGY ELLIPTA®（全再乐），通用名为氟替美维吸入粉雾剂，由GSK（葛兰素史克）研发，于2017年9月首次在美国获批上市，首次获批适应症为慢性阻塞性肺疾病（COPD），2020年9月，哮喘适应症获FDA批准。2019年11月4日原研在中国获批进口。氟替美维吸入粉雾剂是首个每日一次的单吸入器三联疗法制剂，由糠酸氟替卡松、乌美溴铵和三苯乙酸维兰特罗三个活性成分组成。糠酸氟替卡松是一种合成三氟化皮质类固醇，具有抗炎活性；乌美溴铵是一种长效毒蕈碱拮抗剂，具有支气管扩张作用；维兰特罗是一种长效肾上腺素受体激动剂，具有松弛支气管平滑肌作用。 GSK与Theravance（现为Innoviva Inc）长期合作，共同开发该药物，并在全球范围内推广。重要交易事件包括：2002 年 11 月，Theravance 与 GSK 结成联盟开发用于治疗呼吸系统疾病的长效 β-2 激动剂；2017 年 9 月，Theravance 获得氟替美维吸入粉雾剂在欧洲的经济权益；2020 年 9 月，双方合作开发的哮喘新适应症获美国 FDA 批准。 2.临床应用：氟替美维吸入粉雾剂与上一代二联疗法相比临床优势显著与氟替卡松糠酸酯/维兰特罗和乌美溴铵/维兰特罗相比，氟替美维吸入粉雾剂治疗显示肺功能显著改善。第52周，氟替美维吸入粉雾剂与氟替卡松糠酸酯/维兰特罗相比，FEV1谷值（给药前）与基线相比的平均变化为97mL（95%CI：85,109；P<0.001），氟替美维吸入粉雾剂与乌美溴铵/维兰特罗相比，FEV1谷值与基线相比的平均变化为54mL（95%CI：39,69；P<0.001）。一项试验分别比较了氟替美维吸入粉雾剂与糠酸氟替卡松/维兰特罗和乌美溴铵/维兰特罗二联疗法治疗中度和中度COPD的病情加重情况，试验主要终点为平均年加重发生率。结果显示，与糠酸氟替卡松/维兰特罗相比，使用氟替美维吸入粉雾剂治疗年加重发生率可显著降低15%；与乌美溴铵/维兰特罗相比，可显著降低25%。 3.市场表现与研发进展：新一代COPD和哮喘三联疗法，全球销售额超60亿美元氟替美维吸入粉雾剂是FDA批准的首款治疗COPD和哮喘的每日一次单吸入器三联疗法制剂，与上一代二联疗法（糠酸氟替卡松/维兰特罗、乌美溴铵/维兰特罗）相比可显著改善COPD患者肺功能，缓解症状和急性加重，降低死亡率。得益于其显著的临床优势，近年来原研氟替美维吸入粉雾剂全球销售额节节攀升，增速有放缓趋势，截至2023年末全球销售额达64.51亿美元，中国市场销售额约0.37亿美元，仅占全球市场的0.57%。氟替美维吸入粉雾剂目前仅用于治疗COPD和哮喘，未开发其他新适应症。COPD适应症在全球主流国家/地区均已获批，哮喘适应症在美国、日本已获批，但在欧盟申请扩哮喘适应症未被批准，理由是欧洲药品管理局认为原研公司提供的临床证据不足以证明其对哮喘的疗效。目前，哮喘适应症在中国还处于III期临床阶段。 4.专利情况与仿制前景：正大天晴或将成为新一代三联疗法的仿制头马氟替美维吸入粉雾剂为药械一体化产品，在中国的核心专利包括活性成分化合物专利、药物组合物专利以及给药装置专利。氟替美维吸入粉雾剂原研中美核心专利信息一览目前，其3种活性成分化合物专利以及3种成分的药物组合物专利在中国均已处于无效状态，给药装置专利权预计2026年7月27日届满失效，专利保护期已不足两年，但原研在专利信息登记平台登记的专利信息不包含给药装置专利。国内暂无仿制药研发信息，推测原因可能一方面是药械一体化吸入制剂研发难度较大，另一方面是参比制剂2024年8月28日刚正式公布。正大天晴作为国内吸入药物药械一体化设计与制造、哮喘精准诊断药物领域领先企业，已跟进研发COPD/哮喘二联疗法——糠酸氟替卡松维兰特罗吸入粉雾剂和乌美溴铵维兰特罗吸入粉雾剂多年，目前两款药物处于BE试验阶段。由于具有一定的研发基础，推测正大天晴有望成功突破氟替美维吸入粉雾剂（氟替美维吸入粉雾剂）的给药装置专利壁垒，成为新一代三联疗法的仿制头马。结语随着ENTRESTO®、TRELEGY ELLIPTA®等重磅小分子药品专利的即将到期，仿制药企业迎来了新的发展机遇。然而，专利挑战与仿制研发的道路并非一帆风顺，需要企业具备强大的研发实力和战略眼光。同时，政府也应继续完善药品专利链接制度，为原研药企业和仿制药企业提供公平、透明的竞争环境，共同推动医药产业的健康发展。 END 本文为原创文章，转载请留言获取授权专利即将到期五大重磅小分子药品下期内容预告一、三大重磅小分子药专利到期，BI、BMS巨头面临挑战，百亿市场迎变局二、5款重磅小分子药品专利到期全解析：专利攻防策略、专利制度意义和影响近期将持续更新，敬请期近期热门资源获取【摩熵咨询】以终为始，数据助力高质量立项-20240527 【摩熵咨询】市场洞察，精准决策，医疗大数据赋能药企市场准入-2024.5.23 【摩熵咨询】CGT产业现状与未来趋势蓝皮书-20240530 【摩熵咨询】2024年十大重磅小分子药物-20240530 【摩熵咨询】-吸入制剂壁垒高玩家少，国产替代空间广阔-20240604 【摩熵咨询】中药行业现状与未来趋势白皮书-2024.7.8 【摩熵咨询】2023年医药企业综合实力排行榜-20240723 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专利到期

2024-12-16

·Business Wire

Innoviva Specialty Therapeutics Signs Exclusive Distribution and Licensing Agreement to Acquire U.S. Marketing Rights for Zevtera® (ceftobiprole)

BURLINGAME, Calif.--( BUSINESS WIRE )--Innoviva Specialty Therapeutics, Inc., (“IST”) a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced it has entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), for the commercialization of Zevtera ® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the United States. "The licensing of Zevtera expands IST’s diverse yet complementary portfolio of differentiated treatments that address substantial unmet medical needs,” said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc. “We are excited to leverage our operating platform to deliver this important drug to patients. The transaction reinforces the significant opportunity for growth we see in our therapeutics business, building on the momentum and success we have had with our existing marketed products.” In April 2024, the U.S. Food and Drug Administration (FDA) approved Zevtera for three specific treatment indications, and it is the only FDA-approved methicillin-resistant Staphylococcus aureus (MRSA) cephalosporin antibiotic for treating adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB) and endocarditis. Zevtera is indicated for the treatment of adult patients with SAB, including right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). 1 "Zevtera strengthens our role as a provider of essential therapeutics for infectious diseases and critical care within our primary customer base," stated David Altarac, Chief Medical Officer of Innoviva Specialty Therapeutics, Inc. “Drug-resistant pathogens, like MRSA, pose significant challenges for patients in hospitals and other healthcare facilities with a high mortality rate and huge cost burden. Zevtera will enable physicians to treat this important pathogen more effectively, as it is the only approved cephalosporin specifically for MRSA bloodstream infections.” Under the terms of the agreement, Innoviva, Inc., will be granted exclusive marketing rights to Zevtera in the U.S. Basilea will receive a $4 million upfront payment in addition to tiered royalties and milestones on net sales in the U.S. Innoviva Specialty Therapeutics anticipates commercializing Zevtera in mid-year 2025. Reference Full US prescribing information: https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk About Zevtera ® (ceftobiprole medocaril sodium for injection) Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus , including methicillin-resistant strains (MRSA), and Gram-negative bacteria. 1 Outside the U.S., the brand is currently approved and marketed in several countries in Europe and beyond as Zevtera ® and Mabelio ® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements covering more than 80 countries. Important US safety information for ZEVTERA (ceftobiprole medocaril sodium for injection) Contraindications ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class. Warnings and precautions Increased Mortality with Unapproved use in Ventilator-Associated Bacterial Pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved. Hypersensitivity Reactions: Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment. Seizures and other adverse central nervous system (CNS) reactions have been associated with the use of ZEVTERA. If seizures or other CNS adverse reactions occur, evaluate patients to determine whether ZEVTERA should be discontinued. Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA. Evaluate if diarrhea occurs. Adverse reactions SAB (adult patients): The most common adverse reactions occurring in ≥ 4% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia and pyrexia. ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increased, rash, vomiting, and dysgeusia. CABP (adult and pediatric patients 3 months to less than 18 years of age): Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension and dizziness. Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis and pyrexia. For full US prescribing information, please visit here: www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk About Staphylococcus aureus bacteremia (SAB) Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality. Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for SAB. About acute bacterial skin and skin structure infections (ABSSSI) Acute bacterial skin and skin structure infections (ABSSSI) are common infections in the healthcare setting. Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is involved. About community-acquired bacterial pneumonia (CABP) Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. It is the leading cause of infectious disease-related death in the US. For full prescribing information go to https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® . Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. ANORO ® , RELVAR ® and BREO ® are trademarks of the GSK group of companies.

引进/卖出上市批准

100 项与糠酸氟替卡松/三苯乙酸维兰特罗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	糠酸氟替卡松/三苯乙酸维兰特罗	R03AK10	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性支气管炎	日本	GlaxoSmithKline KK	2016-12-02
肺气肿	日本	GlaxoSmithKline KK	2016-12-02
哮喘	日本	GlaxoSmithKline KK	2013-09-20
慢性阻塞性肺疾病	美国	Glaxo Group Ltd.	2013-05-10

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
运动诱发哮喘	临床3期	-	GSK Plc	2012-01-01
动脉僵硬	临床3期	美国	GSK Plc	2011-03-04
动脉僵硬	临床3期	德国	GSK Plc	2011-03-04
动脉僵硬	临床3期	挪威	GSK Plc	2011-03-04
动脉僵硬	临床3期	菲律宾	GSK Plc	2011-03-04
动脉僵硬	临床3期	韩国	GSK Plc	2011-03-04
动脉僵硬	临床3期	泰国	GSK Plc	2011-03-04
心血管疾病	临床3期	美国	GSK Plc	2011-01-25
心血管疾病	临床3期	中国	GSK Plc	2011-01-25
心血管疾病	临床3期	日本	GSK Plc	2011-01-25

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ATS2023	N/A	哮喘	-	Fluticasone Furoate/Vilanterol	繭築齋夢鬱壓壓鹹繭網(積繭鏇築鹽夢廠衊觸獵) = Similar proportions of participants experienced ≥1 on-treatment adverse event (AE) in both populations (5-17 year-olds: n=181/454 [40%] receiving FF/VI versus n=163/448 [36%] receiving FF; 5-11 year-olds: n=133/337 [39%] receiving FF/VI versus n=122/336 [36%] receiving FF) 製鹽築淵憲繭齋餘夢鑰 (廠衊製網蓋衊網鹽獵鏇 )	-	2023-05-21
ATS2022	N/A	慢性阻塞性肺疾病 \| 哮喘	3,426	Fluticasone furoate/vilanterol 100 µg/25 µg	鑰簾鬱選範艱繭淵壓糧(衊鹹壓夢選蓋壓製繭壓) = 醖醖鏇窪壓選顧憲糧廠網積憲構鏇鑰範選網鹽 (襯鏇繭製遞膚廠膚鹽糧 ) 更多	积极	2022-05-15
				Fluticasone furoate/vilanterol 200 µg/25 µg	鑰簾鬱選範艱繭淵壓糧(衊鹹壓夢選蓋壓製繭壓) = 築夢憲醖夢獵鏇築觸糧網積憲構鏇鑰範選網鹽 (襯鏇繭製遞膚廠膚鹽糧 ) 更多
NCT01551758 (HZC115151, Pubmed \| Ther Adv Respir Dis)	临床3期	慢性阻塞性肺疾病	2,802	Fluticasone furoate/vilanterol 100/25 µg	製構簾鏇獵鏇鹽蓋淵夢(壓壓憲觸齋遞鹽範願網) = 簾製觸繭齋製廠遞鏇獵鑰餘簾窪鬱餘觸憲廠獵 (築襯醖鏇鹽範膚簾選顧 ) 更多	-	2021-01-01
				fluticasone furoate/vilanterol	製構簾鏇獵鏇鹽蓋淵夢(壓壓憲觸齋遞鹽範願網) = 製範齋顧齋顧鑰鏇遞艱鑰餘簾窪鬱餘觸憲廠獵 (築襯醖鏇鹽範膚簾選顧 ) 更多
NCT03380429 (CTgov)	临床4期	哮喘	437	Relvar/Breo+salbutamol (Cohort 1: Data on Maintenance Use Supplied to Par and HCP)	壓憲鹽鬱築壓鏇網憲夢(壓鬱憲獵顧鏇廠選壓憲) = 簾繭築憲簾鹽艱襯餘範簾鹽觸觸鑰遞廠鬱網壓 (鹽範夢衊夢網簾顧艱積, 3.19) 更多	-	2020-02-05
				Relvar/Breo+salbutamol (Cohort 5: No Data Supplied to Par or HCP)	壓憲鹽鬱築壓鏇網憲夢(壓鬱憲獵顧鏇廠選壓憲) = 鬱壓夢鏇艱齋襯鏇遞鏇簾鹽觸觸鑰遞廠鬱網壓 (鹽範夢衊夢網簾顧艱積, 3.19) 更多
NCT01706198 (Asthma Salford Lung, Pubmed \| J Asthma)	临床3期	哮喘维持	4,233	Fluticasone furoate/vilanterol	鏇衊醖醖獵簾鏇築遞鹹(襯憲襯構夢膚鹹鏇鑰製) = 築糧觸糧積醖觸鑰構餘觸鑰鬱淵觸餘顧齋顧廠 (齋築築鏇廠鹹襯築獵鹹 )	积极	2019-07-01
				Fluticasone propionate/salmeterol	鏇衊醖醖獵簾鏇築遞鹹(襯憲襯構夢膚鹹鏇鑰製) = 糧鹹襯鹽鑰鹹鑰範製觸觸鑰鬱淵觸餘顧齋顧廠 (齋築築鏇廠鹹襯築獵鹹 )
NCT01957150 (CTgov)	临床4期	慢性阻塞性肺疾病	283	VI (Participants Administered VI)	獵鹹蓋醖觸鹹醖鹹憲醖(製積憲簾齋築廠壓觸蓋) = 蓋製觸繭鑰憲壓鏇遞餘憲觸鹹壓鹹鏇衊築觸遞 (鹹積鑰餘網鑰遞醖衊夢, 醖選膚獵蓋構齋鬱顧齋 ~ 鹹簾獵簾醖淵構鏇鹹鏇) 更多	-	2019-04-10
				VI (Participants Administered FF/VI)	獵鹹蓋醖觸鹹醖鹹憲醖(製積憲簾齋築廠壓觸蓋) = 繭夢鬱艱繭觸窪繭壓壓憲觸鹹壓鹹鏇衊築觸遞 (鹹積鑰餘網鑰遞醖衊夢, 範顧顧鹹憲糧鏇壓窪窪 ~ 簾鬱遞夢糧壓醖衊鹽膚) 更多
NCT01706198 (Salford Lung Study in Asthma \| Asthma Salford Lung \| SLS asthma, CTgov)	临床3期	哮喘	4,233	fluticasone furoate + vilanterol+inhaled corticosteroid	廠鹹衊壓壓繭鹽鬱襯選 = 顧鏇憲觸製鬱遞膚遞廠窪範鏇餘衊窪壓獵獵鹹 (鏇鹽築範醖構獵觸網憲, 蓋遞餘鬱夢網夢築憲積 ~ 蓋衊鏇鹹夢遞艱鏇壓醖) 更多	-	2019-01-24
NCT02301975 (GSK study 201378, Pubmed \| J Asthma)	临床3期	哮喘	1,504	Fluticasone furoate/vilanterol 100/25 µg	襯蓋蓋築範憲構簾繭夢(廠醖艱鑰壓餘餘觸簾窪) = 觸選網鏇網製醖膚鹽醖淵鏇餘網淵艱餘顧鏇願 (醖鬱衊願蓋鹽蓋憲糧醖 )	-	2018-09-01
NCT02730351 (201832, CTgov)	临床4期	哮喘 \| 运动诱发哮喘	75	Placebo+FF/VI (FF/VI 100/25 µg QD Via ELLIPTA + Placebo BID Via DISKUS)	艱繭糧觸艱選製蓋廠網(鬱鬱廠範鹽憲觸鹹糧鏇) = 壓衊鏇鏇獵製願顧夢糧膚膚夢糧範積遞積憲壓 (鑰衊衊鏇顧獵繭衊鑰鹽, 1.058) 更多	-	2017-10-13
				FP (FP 250 µg BID Via DISKUS + Placebo QD Via ELLIPTA)	艱繭糧觸艱選製蓋廠網(鬱鬱廠範鹽憲觸鹹糧鏇) = 顧鏇醖鑰齋衊選鹹積獵膚膚夢糧範積遞積憲壓 (鑰衊衊鏇顧獵繭衊鑰鹽, 1.095) 更多
SLS (ERS2017)	N/A	哮喘	-	Fluticasone furoate/vilanterol (FF/VI) 100/25 µg	積夢顧鏇獵網獵遞鏇鏇(鹹廠構獵製衊餘築製獵) = 壓繭鑰鑰廠繭觸繭窪鑰遞鬱淵餘鹹膚顧觸艱積 (淵製範觸夢選網簾積窪 )	-	2017-09-01
				Fluticasone furoate/vilanterol	積夢顧鏇獵網獵遞鏇鏇(鹹廠構獵製衊餘築製獵) = 選壓鑰膚範遞鏇簾鹹顧遞鬱淵餘鹹膚顧觸艱積 (淵製範觸夢選網簾積窪 )