FDA Green-Lights New Antibiotic for UTIs

The FDA has approved a new medication to treat uncomplicated urinary tract infections (UTIs) in women and girls aged 12 or older. It is the first in a new class of oral antibiotics approved for this condition in nearly 30 years.

UTIs are common bladder infections that typically affect women without underlying health issues. About half of all women get a UTI at least once in their lifetime, and 30% may face recurring infections. Treating these recurrences can be challenging when standard antibiotics fail due to antibiotic resistance, highlighting the need for new treatment options.

The drug, known as gepotidacin but sold under the name Blujepa, works in a unique way by blocking two key enzymes that bacteria need to grow and multiply. This dual-targeted action makes it harder for bacteria to develop resistance quickly, providing a promising option for treating infections that may no longer respond to standard antibiotics.

In two studies with over 3000 women and children who had a mild UTI, Blujepa, a pill taken twice a day for 5 days, worked as well as or better than nitrofurantoin, a common UTI antibiotic. In one study, slightly more people got better with Blujepa (50.6% vs 47.0%), while in another, Blujepa was much more effective (58.5% vs 43.6%).

Side effects are considered mild, with the most common ones being diarrhea and nausea. Blujepa’s development was partially supported by federal grants from the US government’s Center for the Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency, according to a press release by GSK, the drug’s maker. The medication is expected to be available in the US by the second half of this year.

SOURCE:

GSK: “Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older.”