BRIEF—FDA accepts Merck's gefapixant NDA for review

Merck & Co announced today that the US Food and Drug Administration has accepted for review the company’s New Drug Application (NDA) for gefapixant, an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.

This application for gefapixant will be discussed at an upcoming advisory committee meeting, for which no date has been set yet, the US pharma giant said.

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of December 21, 2021.

Dr Roy Baynes, senior vice0 president and head of global clinical development, chief medical officer, Merck Research Laboratories, commented: “If approved by the FDA, gefapixant would be the first medicine approved specifically to help these patients.”

Gefapixant is currently forecast to sell $165 million in 2026, according to sell-side consensus from EvaluatePharma.

The NDA is based on results from the COUGH-1 and COUGH-2 clinical trials, which are the first companion Phase III studies ever conducted in patients with RCC, a cough that persists despite appropriate treatment of underlying conditions, or UCC, a cough where the underlying cause cannot be identified despite a thorough evaluation.