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GSK's antibiotic gets FDA priority review for oral treatment of gonorrhoea
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GSK's antibiotic gets FDA priority review for oral treatment of gonorrhoea
Aug 10, 2025 11:40 PM

Aug 11 (Reuters) - 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.

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