Blujepa, which treats UTIs in female patients aged 12 and up with common and uncomplicated infections, will hit the market in the second half of this year.
The FDA on Tuesday approved GSK’s oral antibiotic gepotidacin for the treatment of uncomplicated urinary tract infections. The drug will be marketed under the brand name Blujepa.
The approval covers female patients aged 12 years and up who weight at least 40 kg and is indicated for uncomplicated infections caused by common bacteria Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis. According to GSK, Blujepa is the first new class of oral antibiotic for this indication in nearly three decades.
GSK plans to launch Blujepa in the second half of 2025.
Tuesday’s approval is backed by data from two pivotal Phase III trials. In EAGLE-2, Blujepa was non-inferior to the antibiotic nitrofurantoin, currently the standard for uncomplicated UTIs. More than half of Blujepa-treated patients achieved treatment success, as compared with 47% in nitrofurantoin comparators.
EAGLE-3 found Blujepa to be significantly better than nitrofurantoin, resulting in a 58.5% therapeutic success rate, versus 43.6% in controls. Both studies also showed that Blujepa was safe and well-tolerated, with side effects being mostly mild or moderate in severity. Common toxicities included diarrhea and nausea.
GSK Chief Scientific Officer Tony Wood called Tuesday’s regulatory win a “crucial milestone” for patients with uncomplicated urinary tract infections, which are “among the most common infections in women.” Some 16 million women in the U.S. suffer from this condition annually, with more than half of women affected in their lifetime. Of these, roughly a third experience at least one recurrent episode.
Elsewhere in GSK’s infectious disease franchise, the pharma earlier this month reported results for its ViiV Healthcare-partnered long-acting antiviral drugs VH499 and VH184 in HIV. The companies reported market viral load suppression for both drugs, laying the groundwork for their further development.
Last month, GSK won the FDA’s approval for its meningococcal shot Penmenvy, which can now be used in patients aged 10 through 25 years to induce protection against the five major Neisseria meningitidis serogroups.
Meanwhile, in January, the FDA ordered GSK—alongside Pfizer—to amend the label of their respiratory syncytial virus vaccines Arexvy and Abrysvo to include warnings about the risk of Guillain-Barré syndrome (GBS).
“The overall body of evidence suggests increased risks of GBS with Abrysvo and Arexvy, but that available evidence is insufficient to establish a causal relationship,” the FDA wrote at the time, citing its own post-marketing assessment of the vaccines. Arexvy showed seven excess cases of GBS per million inoculations in seniors aged 65 and up.
