FDA Approves GSK’s Blujepa: First New Oral Antibiotic for UTIs in Nearly 30 Years
FDA Approves GSK’s Blujepa: First New Oral Antibiotic for UTIs in Nearly 30 Years
The U.S. Food and Drug Administration (FDA) has approved GSK’s Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients aged 12 years and older. GSK
Blujepa represents the first in a new class of oral antibiotics for uUTIs in nearly 30 years. It is specifically indicated for uUTIs caused by susceptible microorganisms, including Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis. GSK
The approval was based on data from two pivotal Phase III trials, EAGLE-2 and EAGLE-3, which demonstrated Blujepa’s efficacy in treating uUTIs. GSK plans to launch Blujepa in the U.S. in the second half of the year. GSK, Reuters
This development is part of GSK’s broader strategy to expand its infectious diseases portfolio and address the growing challenge of antibiotic resistance.
