Wed. Mar 26th, 2025

Urinary tract infections (UTIs) are among the most common medical issues women experience; up to 60% of women will get one during their lifetime. Older, post-menopausal women are especially susceptible, since lower estrogen levels can lead to decreased levels of beneficial bacteria that suppress infection-causing bacteria.

On March 25, the U.S. Food and Drug Administration (FDA) approved the first new antibiotic to treat UTIs in 30 years. The medication, gepotidacin, targets E. coli bacteria, which is responsible for the most common types of infections, called uncomplicated UTIs, that affect women.

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Called Blujepa, the drug works differently than existing antibiotics. It targets two enzymes that E. coli uses to make more copies of itself when it generates and snips off circles of its DNA. During that process, the DNA can become knotted, but the bacteria can undo those knots. Blujepa interferes with that process, which prevents the bacteria from replicating and producing more bacteria that can infect cells.

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Tony Wood, chief scientific officer at GSK (which makes Blujepa), said during a press briefing that this process is unique to E. coli bacteria, and the fact that the drug focuses on this unique property could make it harder for the bacteria to develop resistance against the drug. Existing antibiotics that are used to treat UTIs have broad activity against a number of bacterial species—which makes it more likely that bacteria can find ways to develop resistance to them.

In two large trials of the drug that the FDA reviewed for approval, Blujepa was as good as or slightly better than another commonly prescribed antibiotic for UTIs, nitrofurantoin. Blujepa successfully treated 50% and 58% of women, respectively, in the two studies with infections, compared to nitrofurantoin’s success rate of 43% and 47%.

GSK is also studying the drug against other E. coli infections in the body, including gonorrhea, Wood says.

In addition, the company is working on another antibiotic to treat complicated UTIs, in which the infection spreads beyond the bladder and into other tissues. These infections often require hospitalization and a longer course of treatment. That drug could potentially help keep people out of the hospital or reduce their stay if they do need more intensive care.

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