“The FDA approved gepotidacin for the treatment of uncomplicated UTIs in women and adolescent girls aged 12 years or older, GSK announced.

It is the first new antibiotic for the treatment of uncomplicated UTIs (uUTIs) in nearly 30 years, according to GSK. 

The decision to approve gepotidacin, which will be marketed as Blujepa, was supported by positive phase 3 data from the EAGLE-2 and EAGLE-3 trials, which demonstrated the antibiotic’s noninferiority to standard-of-care treatment nitrofurantoin.

Data from the EAGLE-2 trial showed treatment success in 50.6% of participants vs. 47% in patients treated with nitrofurantoin, with an adjusted difference in success of 4.3 percentage points.”

From Healio.