Merck to face FDA adcomm in November over previously rejected potential chronic cough drug
The FDA announced this morning that on Nov. 17 it will hold an advisory committee meeting to take another look at Merck’s gefapixant for chronic cough.
While European regulators signed off on gefapixant in July, the oral tablets ran into a complete response letter from FDA back in January 2022, with the company saying FDA sought “additional information related to measurement of efficacy. The CRL was not related to the safety of gefapixant.”
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