Roy Baynes, Merck Research Laboratories CMO (file photo)

FDA says it needs a lit­tle more time to de­cide on Mer­ck­'s P2X3 for chron­ic cough

A few months ago, Mer­ck emerged as a clear leader among a group of drug­mak­ers rac­ing through the clin­ic with a new class of ther­a­pies for chron­ic cough. But it looks like the Ke­nil­worth, NJ-based phar­ma will now be tak­ing an­oth­er lap.

The FDA is de­lay­ing its de­ci­sion on Mer­ck’s gefapix­ant by at least a few months to “pro­vide time for a full re­view of the sub­mis­sion,” the com­pa­ny re­vealed in an SEC fil­ing. The agency, which orig­i­nal­ly set a PDU­FA date for Dec. 21, now ex­pects to make a de­ci­sion by March 21.

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