New antibiotics to treat stubborn urinary tract infections (UTIs) and intravenous treatment of blood clotting for acute ischemic stroke have been approved by the US Food and Drug Administration (FDA). It has been nearly 30 years since adjacent treatments entered the market to treat their respective conditions.
This is as announced last week that an additional 3,500 jobs at the FDA will be cut. This means that existing review staff will be reduced twice the workload due to previous personnel losses. But for now, there is good news in some health areas where these two drugs are getting a green light.
GSK’s Blujepa (Gepotidacin) will be the first of a new class of oral antibiotics to treat uncomplication UTIs (also known as Uutis) in nearly 30 years, and will be the first antibiotic of infection-causing E. coli, Klebsiella Pneumoniae, Citrobacter freundii complex, Staphylococcus sapecucus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus coccus co
More than half of all women sign this kind of UTI in their lifetime, with almost a third battling repetitive episodes. Blujepa is expected to be commercially available in the US in the second quarter of 2025 for women over the age of 12.
“The approval of Blujepa is an important milestone with Ooty among the most common infectious diseases in women,” said Tony Wood, GSK’s Chief Science Officer. “We are proud to develop the first Blujepa of Ooty’s new class of oral antibiotics in nearly 30 years, bringing another option for patients given recurrent infections and increased resistance to existing treatments.”
Blujepa is a bacterial triazacenaphthylene antibiotic with a novel mechanism to inhibit bacterial DNA replication. It is also highly effective in abolishing a wide range of pathogens, reducing the risk that bacteria will develop resistance to it.
“For many people, Ooty can be a burden that has a serious impact on everyday life,” said Thomas Hooton, MD, professor of clinical medicine, University of Miami School of Medicine. “With the growing number of patients experiencing recurrent infections, continuing research into antibiotics is clearly needed to address the ongoing patient challenges and the burden of the health care system.”
Meanwhile, the FDA has approved Genetech’s Tnkase to treat adults suffering from acute ischemic stroke. Thnkase (Tenecteplace) is a single-dose intravenous bolus faster and easier than Activase (Alteplase), another existing drug on the market, almost 30 years after that particular treatment is approved.
Essentially, Tnkase is just one dose, working to dissolve the clots and in contrast to the previous actibase, which requires 2-60 minute intervals.
“Acknowledgement today is an important step and highlights our commitment to advancing stroke treatment options for patients,” said Levi Garraway, Chief Medical Officer and Global Product Development Officer at Genentech. “Tnkase offers faster and simpler dosing, which is important for those dealing with acute stroke.”
Here, rapid administration of Tnkase is important. Here, time is important to relieve brain damage and stop the progression of nerve and tissue degradation after stroke. This medication is given in just 5 seconds within three hours of the first sign of stroke symptoms.
Source: GSK, Genetech
