FDA Approves GSK's Blujepa for UTI Treatment

The US Food and Drug Administration has approved GSK's Blujepa, a new oral antibiotic for treating uncomplicated urinary tract infections (UTIs) in women and girls aged 12 and older. Chemically known as gepotidacin, Blujepa is the first new oral antibiotic for UTIs in nearly three decades and is effective against resistant bacteria. Developed with partial funding from US government grants, the antibiotic targets two bacterial enzymes, reducing the likelihood of resistance development. This approval is significant for GSK, which aims to bolster its infectious diseases portfolio amidst patent losses. GSK plans to launch Blujepa in the US in late 2025, with trials showing its superiority over current standard treatments. The drug is expected to address a condition affecting over half of all women, marking a crucial win for GSK.