FDA Approves UTI Antibiotic, Blujepa

GSK announced that the FDA has approved Blujepa (gepotidacin), an antibiotic designed to treat uncomplicated urinary tract infections (uUTI) in pediatric female patients ages 12 and older who weigh at least 88 lbs., as well as in adult females, according to a recent news release. A commercial launch is expected in the second half of 2025.

Blujepa is approved to treat uUTIs caused by the following microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis. This approval is significant because of the increasing rates of uUTIs caused by drug resistant bacteria.

“For many, uUTIs can be a burden that severely impacts daily life,”
 Thomas Hooton, M.D., professor of clinical medicine at the University of Miami School of Medicine, said in the news release. “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.”

uUTIs are the most common infection among women, affecting up to 16 million women in the United States annually, according to the release. More than half of all women will experience a uUTI in their lifetime, with 30% having at least one recurrent infection.

This approval is based on results from the phase 3 EAGLE-2 and EAGLE-3 trials, which demonstrated that 58.5% of the 277 patients treated with Blujepa saw symptom improvement, compared with 43.6% of the 264 patients treated with nitrofurantoin, a leading uUTI treatment, the release says.

Safety was evaluated in 1,570 patients who received Blujepa and in 1,558 patients who received nitrofurantoin. The most common adverse events associated with Blujepa were diarrhea (16%) and nausea (9%), compared with 3% and 4%, respectively, in nitrofurantoin patients.

Blujepa is a first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication.

Blujepa is available as a 750 mg tablet. The recommended dosage is 1,500 mg (two 750 mg tablets) taken twice a day for five days, according to the prescribing information.

Patients taking CYP3A4 inhibitors, inducers or substrates should not take Blujepa. The CYP3A4 enzyme helps the body metabolize drugs and depending on the medication, CYP3A4 can alter its effectiveness.

Pricing details for Blujepa are forthcoming, according to an email sent by a GSK representative to Managed Healthcare Executive.