GSKs Blujepa will be available later this year
of ConsumerAffairsThe U.S. Food and Drug Administration has granted approval to a new antibiotic to treat urinary tract infections in women and adolescent girls. The drug is made by British pharmaceutical company GSK.
The drug will be sold under the brand name Blujepa and is approved for use by females aged 12 and older. It is specifically designed to treat common UTIs, which are bacterial infections of the lower urinary tract.
GSK said it intends to begin marketing the drug in the U.S. later this year. The company said Blujepa represents a significant advancement in UTI treatment, as it is the first new class of oral antibiotics for uUTIs in nearly three decades. In trials, the drug was effective against common UTI-causing bacteria, including Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.
"The approval of Blujepa is a crucial milestone, with uUTIs among the most common infections in women," Tony Wood, chief scientific officer at GSK, said in a press release. "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."
Prevalent health issue
UTIs are a prevalent health issue, affecting up to 16 million women in the U.S. annually. Over half of all women experience a UTI in their lifetime, with approximately 30% facing recurrent episodes. The increasing prevalence of drug-resistant bacteria contributing to UTIs has highlighted the need for new treatment options, GSK said.
The FDA's approval is based on positive results from the EAGLE-2 and EAGLE-3 phase III clinical trials, which demonstrated Blujepa's non-inferiority and, in one trial, statistical superiority to nitrofurantoin, a standard treatment for UTIs. In EAGLE-2, Blujepa showed non-inferior therapeutic success compared to nitrofurantoin. In EAGLE-3, Blujepa demonstrated statistically significant superiority.
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Posted: 2025-03-26 11:17:41
