Up­dat­ed: Cit­ing ef­fi­ca­cy, GSK halts UTI an­tibi­ot­ic tri­al ear­ly, plans to file for FDA ap­proval next year

GSK an­nounced this morn­ing that it is wrap­ping up two large clin­i­cal tri­als on a new an­tibi­ot­ic for un­com­pli­cat­ed uri­nary tract in­fec­tions ear­ly, set­ting it up for an FDA fil­ing next year.

An in­de­pen­dent re­view group flagged that the non-in­fe­ri­or­i­ty tri­als test­ing GSK’s gepoti­dacin ver­sus ni­tro­fu­ran­toin al­ready met their pri­ma­ry end­points in an in­ter­im analy­sis, ac­cord­ing to GSK. The news comes as there are in­creas­ing con­cerns around drug-re­sis­tant UTIs and a lack of new an­tibi­ot­ic op­tions for the com­mon in­fec­tion that some stud­ies es­ti­mate im­pacts over half of all women in their life­time.

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