British drugmaker GSK announced on Monday that the U.S. Food and Drug Administration (USFDA) has accepted its application for priority review of gepotidacin, an oral antibiotic for the treatment of sexually transmitted uncomplicated gonorrhoea.
The company is focusing on new infectious disease therapies, including its recently launched respiratory syncytial virus (RSV) vaccine, to counter revenue losses from top-selling products and expected patent expirations for its HIV drugs.
Gepotidacin, already approved in the U.S. under the brand name Blujepa for treating common urinary tract infections (UTIs) in women and adolescent girls, is now under review for uncomplicated urogenital gonorrhoea. The FDA’s decision is expected in December. If approved, it would offer patients an oral alternative to existing injectable treatments.