Azithromycin Hydrochloride

RTI International congratulates Vietnam in eliminating trachoma – a painful disease impacting the lives of millions of people around the world RESEARCH TRIANGLE PARK, N.C., Oct. 21, 2024 /PRNewswire/ -- RTI International, a nonprofit research institute and leading international development organization, is pleased to join Vietnam, the World Health Organization (WHO) and the United States Agency for International Development (USAID) in celebrating the elimination of trachoma, a painful disease that can lead to blindness, as a public health problem in Vietnam. Globally, Vietnam is the 21st endemic country to achieve validation of elimination of this neglected tropical disease (NTD). More than 8.3 million people in Vietnam are now free from the risk of trachoma infection. The announcement came at the opening of the WHO Regional Committee for the Western Pacific, being held in Manila, Philippines. "We applaud Vietnam for achieving this incredible goal, which has been over half a century in the making," said Tim J. Gabel , president and CEO at RTI International. "Solving this health problem is an important achievement in improving the human condition and we are proud to be among the partners that assisted in this effort." Trachoma, the leading infectious cause of blindness worldwide, causes eyelids to scar and eyelashes to turn inwards eventually resulting in blindness if untreated. Surgery, antibiotics, facial cleanliness practices and environmental improvements (the SAFE strategy) is the WHO endorsed method for eliminating the disease as a public health problem, including the provision of treatment and care for those at risk for the disease. Trachoma control was first initiated in Vietnam in the 1950s; at that time, the prevalence of active trachoma in some communes was as high as 50-90%. In 1999, the Government of Vietnam established a national trachoma program and began mass treatment campaigns with donated azithromycin. USAID began partnering with Vietnam in 2011 to support their efforts to eliminate trachoma. In recent years, USAID's Act to End Neglected Tropical Diseases | East program, through RTI and partner Fred Hollows Foundation, has supported the government to conduct surveys to monitor prevalence of the disease and ensure care has been provided to those impacted by the disease. These efforts and additional technical assistance have supported the Government of Vietnam to formally document their successes to WHO for validation of trachoma elimination as a public health problem. "This achievement would not have been possible without the commitment of the Government of Vietnam to trachoma elimination," says Lisa Rotondo, program director for USAID's Act to End NTDs | East Program at RTI. "The task now will be for Vietnam to continue surveillance for resurgence and to provide care for those already impacted." Additional partners that have contributed to Vietnam's success include the International Trachoma Initiative, the Australian Department of Foreign Affairs and Trade, Tropical Data, and FHI 360, among others. Over the past 18 years, with support from USAID, RTI has partnered with governments and other countries, including Vietnam, Lao People's Democratic Republic, Cambodia and Nepal, to achieve trachoma elimination as a public health problem. Through the USAID Act | East Program, RTI will continue to support countries in Africa, Asia and the Americas in ending NTDs, such as trachoma. Learn more about RTI's work to control and eliminate NTDs around the globe  Media Contact: Kerry Branon 919-541-7300 [email protected] SOURCE RTI International WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

16 October 2024 Application supported by positive results from pivotal phase III EAGLE-2 and EAGLE-3 trials 26 March 2025 assigned as action date for FDA decision Gepotidacin could be the first in a new class of oral antibiotic treatment for uUTIs in over 20 years GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for the treatment of female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs). The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of 26 March 2025. Over half of all women are affected by uUTIs in their lifetime1, with approximately 30% suffering from recurrent disease which can cause significant patient burden, including discomfort and restriction of daily activities.2 New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing and can result in higher treatment failure rates.3 Gepotidacin is a late-stage antibiotic in GSK’s growing infectious disease portfolio and could be the first in a new class of oral antibiotics for uUTIs in over 20 years. The NDA is supported by positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials. In these studies, gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard of care for uUTI, in female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin. In EAGLE-3, gepotidacin achieved statistically significant superiority versus nitrofurantoin, demonstrating therapeutic success in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin (treatment difference 14.6%, 95% CI (6.4, 22.8)). In EAGLE-2, gepotidacin demonstrated therapeutic success in 50.6% (162/320) of participants compared to 47.0% (135/287) for nitrofurantoin (treatment difference 4.3%, 95% CI (-3.6, 12.1)). The safety and tolerability profile of gepotidacin in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials of gepotidacin. The most commonly reported adverse events (AEs) in gepotidacin participants were gastrointestinal (GI). Diarrhoea was the most common (16% of participants), followed by nausea (9%). Of the participants who reported GI AEs in the gepotidacin group, the maximum severity were mild (69% Grade 1) and moderate (28% Grade 2). Participants with Grade 3 GI events accounted for 3% of all patients with GI events and occurred in <1% of all participants. There was one drug-related serious adverse event in each treatment arm (gepotidacin and nitrofurantoin) across the two trials. The development of gepotidacin has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C and with federal funds awarded by the Defense Threat Reduction Agency under agreement number HDTRA1-07-9-0002. About the EAGLE (Efficacy of Antibacterial Gepotidacin Evaluated) phase III programme The global phase III clinical programme for gepotidacin in adults and adolescents consists of three trials: EAGLE-2 and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and safety of gepotidacin (1,500mg administered orally twice daily for five days) to nitrofurantoin (100mg administered orally twice daily for five days) with 1531 and 1605 female adults and adolescents with uncomplicated urinary tract infections, respectively. Across both trials, the duration of follow-up for participants was approximately 28 days, and the primary endpoint was the combined clinical and microbiological response at the Test-of-Cure (ToC) visit (days 10-13) in patients with qualifying uropathogens susceptible to nitrofurantoin. EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin to ceftriaxone plus azithromycin in 628 patients with uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeae. About gepotidacin Gepotidacin, discovered by GSK scientists, is an investigational bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct binding site, a novel mechanism of action and for most pathogens, provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most target uropathogens (such as E. coli and S. saprophyticus), and N. gonorrhoeae, including isolates resistant to current antibiotics. Efficacy and safety in patients have been demonstrated in uUTI and gonorrhoea phase III clinical trials, including those with drug-resistant pathogens. Due to the well-balanced inhibition, gepotidacin target-specific mutations in both enzymes are needed to significantly affect susceptibility to gepotidacin. Therefore, leading to a lower potential for resistance development. GSK in infectious diseases GSK has pioneered innovation in infectious diseases for over 70 years, and the Company’s pipeline of medicines and vaccines is one of the largest and most diverse in the industry, with a goal of developing preventive and therapeutic treatments for multiple disease areas or diseases with high unmet needs globally. GSK’s expertise and capabilities in innovation, access and stewardship position the Company uniquely to help prevent and mitigate the challenge of antimicrobial resistance. In antimicrobials, in addition to gepotidacin, GSK entered into an exclusive licence agreement with Spero Therapeutics, Inc. in September 2022 to add tebipenem HBr, a late-stage antibiotic and potential treatment for complicated urinary tract infections (cUTIs), to the pipeline and are currently enrolling for PIVOT-PO, a phase III trial. In March 2023, GSK announced an exclusive licence agreement with Scynexis for Brexafemme (ibrexafungerp tablets), a first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and reduction in the incidence of recurrent VVC. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024. References You might also like