GlaxoSmithKline ( (GB:GSK) ) has issued an update.
GSK announced that the US FDA has approved Blujepa (gepotidacin), a first-in-class oral antibiotic for treating uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients aged 12 and older. This approval marks a significant milestone as Blujepa is the first new class of oral antibiotics for uUTIs in nearly 30 years, addressing the growing issue of drug-resistant bacteria. The approval is based on positive results from phase III EAGLE-2 and EAGLE-3 trials, which demonstrated Blujepa’s efficacy and safety compared to the standard treatment, nitrofurantoin. The commercial launch in the US is planned for the second half of 2025, and the development has been partially funded by US federal agencies.
More about GlaxoSmithKline
GSK is a global biopharmaceutical company that focuses on uniting science, technology, and talent to advance disease prevention and treatment. With over 70 years of innovation in infectious diseases, GSK has a diverse pipeline of medicines and vaccines aimed at addressing unmet medical needs worldwide.
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