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The FDA Approves a New Antibiotic for UTIs, the First in Almost Three Decades


The Food and Drug Administration has approved the first new class of antibiotics in nearly 30 years for treating urinary tract infections (UTIs). The drug, called Blujepa, is a pill from GSK approved for women and girls 12 and older with uncomplicated UTIs caused by bacteria like E. coli. Antibiotic resistance is becoming increasingly common, making treatment more difficult, with more than 2.8 million antimicrobial-resistant infections occurring in the U.S. each year.

Blujepa is part of a new class of antibiotics called triazaacenaphthylenes, which work by targeting enzymes that E. coli bacteria need to replicate and survive. The drug was shown in clinical trials to successfully treat 50% to 58% of infections when taken twice a day for five days. More than half of women will experience at least one UTI in their lifetime, and around 30% will experience recurring infections.

GSK is also studying whether Blujepa can treat gonorrhea, and the drug is expected to be available in the second half of the year. While the cost has not been disclosed, as a brand-name drug, it is expected to be higher than generic options. Physicians may still gravitate toward generics, but a new option like Blujepa is helpful in combatting drug resistance due to the overuse of existing antibiotics.

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