U.S. FDA Accepts Merck’s Gefapixant New Drug Application for Review
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) 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. No date has been set yet. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Dec. 21, 2021.
“This submission underscores our commitment to help patients with refractory or unexplained chronic cough who currently have limited treatment options,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “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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The NDA is based on results from the COUGH-1 and COUGH-2 clinical trials, which are the first companion Phase 3 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. Data from COUGH-1 and COUGH-2 were presented at the virtual European Respiratory Society (ERS) International Congress 2020.
About the COUGH-1 and COUGH-2 Trials
COUGH-1 (NCT03449134) and COUGH-2 (NCT03449147) are Phase 3 multinational, randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of gefapixant in reducing cough frequency in adult participants with refractory chronic cough (RCC) or unexplained chronic cough (UCC). A total of 2,044 participants were treated in COUGH-1 (n=730) and COUGH-2 (n=1,314). In both studies, patients were randomly selected to receive one of the following: gefapixant 45 mg twice daily, gefapixant 15 mg twice daily, or placebo. The primary efficacy outcomes measure for COUGH-1 and COUGH-2 were 24-hour cough frequency at week 12 and 24-hour cough frequency at week 24, respectively, measured using an ambulatory digital audio recording device. Secondary endpoints in both trials included awake coughs per hour and percentage of participants with a greater than 1.3-point increase from baseline in the Leicester Cough Questionnaire (LCQ) total score. COUGH-1 had a 12-week treatment period and a 40-week extension period, while COUGH-2 had a 24-week treatment period and a 28-week extension period.