GSK’s antibiotic gets FDA priority review for oral treatment of gonorrhoea
British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for priority review of gepotidacin, an oral antibiotic to treat sexually transmitted uncomplicated gonorrhoea.
GSK is counting on new infectious disease treatments, such as its recently launched respiratory syncytial virus vaccine, to help offset revenue losses from its top-selling drugs and anticipated patent expirations for its HIV therapies.
The drug gepotidacin has already been approved in the United States under the brand name Blujepa for a common type of urinary tract infection (UTI) in women and adolescent girls.
The FDA’s decision on the drug’s treatment of uncomplicated urogenital gonorrhoea is expected in December. If approved, it would provide an oral option to patients who currently rely on injectable treatments.
