First new stroke and UTI drugs in 30 years get FDA approval
March 30, 2025
FDA gives the green light to two important new therapeutics
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A new antibiotic to treat stubborn urinary tract infection (UTI) and a blood-clot-dissolving intravenous treatment for acute ischemic stroke have been granted approval by the US Food and Drug Administration (FDA). It’s been nearly three decades since adjacent treatments have entered the market to treat their respective conditions.
This comes as it was announced last week that a further 3,500 jobs at the FDA would be cut, with some existing review staff now with double the workload due to previous personnel losses. But for now, it’s good news in some health fields with these two drugs getting a green light.
GSK’s Blujepa (gepotidacin) becomes the first in a new class of oral antibiotics to treat uncomplicated UTIs (also known as uUTIs) in almost 30 years, taking aim at infection-causing bacteria Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.
More than half of all women will contract this kind of UTI in their lifetime, and almost a third will battle recurring episodes. Blujepa, for females aged 12 and over, is expected to be available commercially in the US in the second quarter of 2025 – so, very soon.
“The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women,” said Tony Wood, Chief Scientific Officer at GSK. “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.”
Blujepa is a bactericidal, first-in-class triazaacenaphthylene antibiotic with a novel mechanism that inhibits bacterial DNA replication. And because it has high efficacy in disabling a broad range of pathogens, it also comes with low risk of bacteria developing resistance to it.
“For many, uUTIs can be a burden that severely impacts daily life,” said Thomas Hooton, MD, Professor of Clinical Medicine, University of Miami School of Medicine. “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.”
Meanwhile, the FDA also approved Genetech’s TNKase to treat adults who suffer acute ischemic stroke. THNKase (tenecteplace) is a single-dose intravenous bolus that is faster and easier to administer than the only other existing drug on the market, Activase (alteplase) – and it comes nearly 30 years after that particular treatment was approved.
Essentially, TNKase goes to work immediately to dissolve blood clots and is just one dose, as opposed to the preceding Activase that requires two, 60 minutes apart.
“Today’s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” said Levi Garraway, MD, Chief Medical Officer and head of Global Product Development at Genentech. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”
The rapid administration of TNKase is important here, where time is critical in relieving damage to the brain and halting the progression of nerve and tissue deterioration following a stroke. The drug will be administered in just five seconds, within three hours of the first sign of stroke symptoms.
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