The FDA has issued a complete response letter declining to approve a new drug application for gefapixant as a treatment for adults with refractory or unexplained chronic cough. This decision follows a recommendation given by the FDA’s Pulmonary-Allergy Drug Advisory Committee, and is not related to the safety of the drug. There are currently no FDA-approved therapies for this condition, and Merck, the manufacturer of gefapixant, stated that they will figure out next steps after reviewing the letter. They expressed disappointment in the FDA’s response to their application and thanked clinical trial participants and investigators for their contributions to the body of knowledge related to chronic cough.
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FDA declines to approve gefapixant for chronic cough a second time
