British pharmaceutical giant GSK said on Saturday (April 15) its oral antibiotic drug to treat uncomplicated urinary tract infections (uUTI) in female adults and adolescents met the main goals in late-stage trials.
The drug, gepotidacin, in phase III trials, met its primary goals of being on a par or better than nitrofurantoin, the current standard of care for the treatment of uUTIs, the company said.
GSK plans to submit results of the trials to the United States Food and Drug Administration for review later in the second quarter.
The drug, if approved, could become the first new type of antibiotic, which is critically important for countering drug-resistant infections, to treat uUTIs in 20 years, the company said.
“Gepotidacin, if approved, will offer a much-needed additional oral treatment option for patients at risk of treatment failure associated with resistance or recurrence of uUTI,” Chris Corsico, senior vice president of development at GSK, said.
More than half of all women globally are affected by uUTIs in their lifetime, GSK said.
In 2021, GSK expected the drug could assume blockbuster status, meaning up to 1 billion pounds in non-risk adjusted peak year sales.