Ceftriaxone Sodium

PHILADELPHIA, PA, USA I March 25, 2025 I GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli , Klebsiella pneumoniae , Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis . Discovered by GSK scientists, Blujepa is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’s infectious diseases portfolio. Tony Wood, Chief Scientific Officer, GSK, said : “The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women. We are proud to have developed Blujepa , the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.” uUTIs are the most common infection in women, impacting up to 16 million women in the US annually. 1-4 Over half of all women are affected by uUTI in their lifetime, 5 with approximately 30% suffering from at least one recurrent episode which can cause significant patient burden, including discomfort and restriction of daily activities. 6 New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing which can result in higher treatment failure rates. 7 Thomas Hooton, MD, Professor of Clinical Medicine, University of Miami School of Medicine said: “For many, uUTIs can be a burden that severely impacts daily life. With an increasing number of patients experiencing recurrent infections, there remains a clear need for continued research of antimicrobials to help address ongoing patient challenges and the strain on healthcare systems.” The approval is based on positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTI, in female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with a confirmed uUTI. In EAGLE-2, Blujepa demonstrated non-inferiority in therapeutic success which occurred in 50.6% (162/320) of participants compared to 47.0% (135/287) for nitrofurantoin (covariate-adjusted treatment difference 4.3%, 95% CI (-3.6, 12.1)). In EAGLE-3, Blujepa demonstrated statistically significant superiority versus nitrofurantoin (one-sided p-value 0.0003). Therapeutic success occurred in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin (covariate-adjusted treatment difference 14.6%, 95% CI (6.4, 22.8)). The safety and tolerability profile of Blujepa in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials. The most commonly reported adverse events (AEs) in Blujepa participants were gastrointestinal (GI). Diarrhea was the most common (16% of participants), followed by nausea (9%). Of the participants who reported GI AEs in the Blujepa group, the most common maximum severity was 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 ( Blujepa and nitrofurantoin) across the two trials. US commercial launch is planned in 2H 2025. The development of Blujepa (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 Blujepa (gepotidacin) Blujepa , discovered by GSK scientists, is a 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 Escherichia coli and Staphylococcus saprophyticus ), and Neisseria gonorrhoeae , including isolates resistant to current antibiotics. Due to the well-balanced inhibition for most pathogens, Blujepa target-specific mutations in both enzymes are needed to significantly affect susceptibility to Blujepa . Therefore, a lower potential for resistance development is expected. Efficacy and safety in patients have been demonstrated in uUTI and gonorrhea phase III clinical trials, including in patients with drug-resistant pathogens. Please see full Prescribing Information including Medication Guide, available here . About the EAGLE (Efficacy of Antibacterial Gepotidacin Evaluated) phase III program The global phase III clinical program for Blujepa (gepotidacin) in adults and pediatric patients consists of three trials: EAGLE-2 and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and safety of Blujepa (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 pediatric patients with uUTIs, respectively. Across both trials, the planned duration of follow-up for participants was approximately 28 days, and the primary endpoint, a stringent composite measure of efficacy, 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 uncomplicated urogenital gonorrhea trial) compared the efficacy and safety of Blujepa to ceftriaxone plus azithromycin in 628 patients with uncomplicated urogenital gonorrhea caused by N. gonorrhoeae . 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. Our expertise and capabilities in infectious disease strongly position us to help prevent disease and mitigate the challenge of antimicrobial resistance (AMR). In antimicrobials, in addition to gepotidacin, GSK entered into an exclusive license 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 license 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. BLUJEPA (gepotidacin) tablets, for oral use Indication(s) and Important Safety Information (ISI) INDICATION BLUJEPA is indicated for the treatment of female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg) with uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms: Escherichia coli , Klebsiella pneumoniae , Citrobacter freundii complex, Staphylococcus saprophyticus , and Enterococcus faecalis . Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of BLUJEPA and other antibacterial drugs, BLUJEPA should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 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 . References 1 Advani SD, et al. Poster presented at: ISPOR 2024; May 5-8, 2024. Presentation EPH17. 2 Foxman B, et al. Urinary tract infection: self-reported incidence and associated costs. Ann Epidemiol . 2000;10(8):509-15. 3 Foxman B. Urinary Tract Infection Syndromes: Occurrence, Recurrence, Bacteriology, Risk Factors, and Disease Burden. Infect Dis Clin North Am . 2014 28(1):1-13. 4 United States Census Bureau. Age and Sex Composition: 2020. [Available from: https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-06.pdf Last accessed March 2025]. 5 Czajkowski, K, et al. Urinary tract infection in women. Prz Menopauzalny . 2021;20(1):40-7. 6 Little P, et al. Presentation, pattern, and natural course of severe symptoms, and role of antibiotics and antibiotic resistance among patients presenting with suspected uncomplicated urinary tract infection in primary care: observational study. BMJ . 2010;340:b5633. 7 Kaye KS, et al. Antimicrobial resistance trends in urine Escherichia coli isolates from adult and adolescent females in the United States from 2011 to 2019: rising ESBL strains and impact on patient management. Clin Infect Dis 2021;73:1992–1999. SOURCE: GlaxoSmithKline

BOSTON--( BUSINESS WIRE )--binx health, a healthcare technology and diagnostics company focused on making routine testing convenient, today announced key findings from a new Massachusetts General Hospital (MGH) study designed to assess the real-world impact of Point of Care (“POC”) testing for Chlamydia trachomatis (“CT”) and Neisseria gonorrhoeae (“NG”) testing in symptomatic patients presenting at a sexual health clinic. The study comes on the heels of The Food and Agriculture Organization of the United Nations (“FAO”), the United Nations Environment Program (“UNEP”), the World Health Organization (“WHO”) and the World Organization for Animal Health (WOAH) welcoming a declaration made at the UN General Assembly meeting, which included the target to reduce human deaths from AMR by 10% by 2030 i . In the USA, antibiotic stewardship has become even more critical since the emergence of new multidrug-resistant gonorrhea strains in Massachusetts in 2023. In response, CDC now recommends the use of high doses of the antibiotic ceftriaxone for treatment ii , making rapid and accurate identification of gonorrhea (NG) even more important to appropriately identify and treat those who are indeed infected and avoiding over treatment in those who are negative. Trials conducted as part of the study focused on comparing the outcomes of POC testing vs Standard of Care (“SOC”) testing as well as key outcomes associated with empiric antibiotic use per patient, time to results, time to etiologic treatment, duration of clinic visit, and implementation potential. The accuracy of binx CT/NG test demonstrated sufficient accuracy to be considered for replacing gram stain SOC testing for both males and females delivering rapid nucleic acid amplification test (NAAT) results 3.75 days faster than the state lab and reduced inappropriate antibiotic treatment by 63%. “Accurate, rapid test results are incredibly helpful for patients and providers,” said Dr. Jana Jarolimova, MD MPH, Infectious Disease Physician, Massachusetts General Hospital. “When clinicians are able to quickly and accurately prescribe treatments in clinic, we can better manage their STIs and ultimately, help patients experience better outcomes.” Today, thirty-five million CT/NG tests are processed annually at central laboratories iii , with most patients leaving the clinic before results are ready. Under this traditional care model, patients who are subsequently determined to be positive for chlamydia or gonorrhea may not return for treatment once they leave the clinic, leading to further infection spread and comorbidities. Findings from the study confirmed that patients want to have their test results before they leave the clinic. 80% of patients acknowledged that they would be willing to wait in clinic for their rapid PCR POC results. Importantly, POC testing can have a dramatic impact on treatment accuracy and improved Healthcare Effectiveness Data and Information Set (“HEDIS”) scores as a standardized measure used to assess the quality of health plans and clinician performance. The 10% improvement observed by MGH for appropriate treatment observed when using the binx CT/NG test over SOC demonstrates positive potential to improve HEDIS scores long term. "Our mission at binx health is to be a key proponent that improves STI care,” said Michael Karsonovich, President of binx health. “The ability to collaborate with Mass General specialist sexual health clinic with this study is a fantastic opportunity to demonstrate how POC testing can truly move the needle in STI diagnosis and treatment. This study allows us to leverage our proprietary technology to identify and assess the benefits of testing and treating in the same visit and the need for transformative technology to help tackle the rise of these infections." About binx health binx health is a healthcare technology and clinical diagnostics company focused on innovating solutions to improve routine testing and convenience, providing timely results to improve patient care. The binx io point-of-care molecular platform is the first ever FDA-cleared, CLIA-waived point-of-care system for the detection of chlamydia and gonorrhea in both males (urine) and females (vaginal swab) that provides central lab performance results in about 30 minutes. The binx io platform is highly flexible, easy to use, and enables rapid testing and treatment in a single patient visit. For more information, visit https://mybinxhealth.com/ i https://www-who-int.libproxy1.nus.edu.sg/news/item/26-09-2024-world-leaders-commit-to-decisive-action-on-antimicrobial-resistance ii https://www-cdc-gov.libproxy1.nus.edu.sg/mmwr/volumes/69/wr/mm6950a6.htm iii Huang W, Gaydos CA et al (2012). Comparative effectiveness of a rapid point-of-care test for detection of Chlamydia trachomatis among women in a clinical setting. Sex Transm Infect. 2013 Mar;89(2):108-14. doi: 10.1136/sextrans-2011-050355. Epub 2012 Sep 14. PMID: 22984085; PMCID: PMC3671871. https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/pmc/articles/PMC3671871/