PHILADELPHIA, PA — The U.S. Food and Drug Administration (FDA) has approved GSK’s Blujepa (gepotidacin), a groundbreaking oral antibiotic for treating uncomplicated urinary tract infections (uUTIs) in adult women and adolescents (≥12 years, ≥40 kg). This marks the first approval of an oral antibiotic for uUTIs in nearly three decades.
Developed by GSK scientists, Blujepa introduces a novel mechanism of action to combat uUTIs caused by drug-resistant bacteria, offering a vital solution as traditional treatments face rising rates of resistance. uUTIs are among the most common infections in women, impacting up to 16 million women in the U.S. annually, with over 30% enduring recurrent episodes.
“The approval of Blujepa is a crucial milestone,” said Tony Wood, Chief Scientific Officer at GSK. “We are proud to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.”
The FDA’s decision follows compelling results from the pivotal Phase III EAGLE-2 and EAGLE-3 trials. Blujepa demonstrated significant efficacy, achieving therapeutic success rates of 58.5% in EAGLE-3 compared to 43.6% for nitrofurantoin, a current standard treatment. Safety data showed that gastrointestinal side effects such as mild diarrhea and nausea were the most common, but generally well-tolerated.
“For many, uUTIs can be a burden that severely impacts daily life,” said Dr. Thomas Hooton of the University of Miami School of Medicine. “The approval of Blujepa highlights the importance of continued research to address patients’ challenges and support healthcare systems.”
GSK plans to launch Blujepa commercially in the U.S. in the second half of 2025, aiming to provide a new standard of care for those suffering from uUTIs. The development was supported in part by federal funding from BARDA and the Defense Threat Reduction Agency, underscoring its importance in addressing public health needs.
Blujepa’s introduction signals a significant advance in the treatment of uUTIs, promising relief for millions of patients struggling with these infections and the evolving challenges of antimicrobial resistance.
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