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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