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Merck: FDA To Review NDA For Gefapixant - Quick Facts

Merck (MRK) said the FDA has accepted for review the company's New Drug Application for gefapixant, an orally administered, selective P2X3 receptor antagonist, for the treatment of refractory chronic cough or unexplained chronic cough in adults. The FDA has set a PDUFA, or target action date, of Dec. 21, 2021.

Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said: "If approved by the FDA, gefapixant would be the first medicine approved specifically to help these patients, and we look forward to participating in the advisory committee meeting and working with the FDA as they review our application."

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