FDA Greenlights Blujepa for Simple UTIs

On March 25, 2025, the U.S. Food and Drug Administration (FDA) reached a significant decision, granting approval for Blujepa (gepotidacin) as a treatment for uncomplicated urinary tract infections (uUTIs) in adult women and children aged 12 and older, all weighing 40 kg or more. This approval marks the introduction of Blujepa as a first-in-class oral antibiotic targeting uUTIs caused by specific bacteria, including Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.

Blujepa's approval followed the successful outcomes of the phase 3 EAGLE-2 and EAGLE-3 clinical trials. These trials assessed the drug's efficacy compared to nitrofurantoin, which is currently one of the standard treatments for uUTIs. The EAGLE-2 trial demonstrated the noninferiority of Blujepa, with 50.6 percent of patients achieving therapeutic success, in contrast to 47.0 percent with nitrofurantoin. More significantly, the EAGLE-3 trial showcased Blujepa's superiority, with a therapeutic success rate of 58.5 percent compared to 43.6 percent for nitrofurantoin.

During these trials, participants commonly reported gastrointestinal adverse events while taking Blujepa, with diarrhea and nausea being the most frequent at 16 percent and 9 percent, respectively. The severity of these side effects was predominantly mild, accounting for 69 percent, and moderate at 28 percent, with severe reactions being rare, occurring in less than 1 percent of participants. Notably, each trial reported one drug-related serious adverse event in both the Blujepa and nitrofurantoin groups.

Tony Wood, the chief scientific officer of GlaxoSmithKline (GSK), expressed the company's satisfaction with the FDA's approval. He emphasized that uUTIs are among the most prevalent infections affecting women, and the advent of Blujepa is the first introduction of a new class of oral antibiotics for these infections in nearly 30 years. Wood highlighted the significance of providing patients with this new treatment option, especially in the face of rising antibiotic resistance and recurrent infections.

The FDA's approval of Blujepa was awarded to GlaxoSmithKline, the company responsible for its development. This new antibiotic offers hope for improved management of uUTIs in a population that continues to face challenges due to increasing resistance to existing treatments.