US FDA declines to approve Merck`s chronic cough drug
FDA panel flags insufficient data for Merck`s chronic cough drug
Merck & Co. is running out of time to get the first chronic cough medicine to market. Its path thus far has been wrought with delays and the future appears no different as the FDA expresses new doubts about the pharma’s candidate.
US FDA staff flags concerns about Merck`s chronic cough drug
Merck`s Lyfnua (gefapixant) Receives Approval in Europe
Merck Receives Positive European Union CHMP Opinion for Gefapixant
Merck & Co. has a new challenger for the chronic cough market: GSK. The British Big Pharma is set to pay $2 billion to buy Bellus Health, securing a late-phase rival to Merck’s stuttering gefapixant program and completing a remarkable, 16-year turnaround for the biotech.
Merck said in a Friday regulatory filing that the FDA’s request in the rejection letter related to the cough counting system used to track efficacy in phase 3 trials for the drug. Safety, however, was not in question by the agency.
The Food and Drug Administration has rejected Merck & Co's experimental drug for chronic cough, issuing the company a complete response letter for a treatment it acquired via a 2016 buyout of drugmaker Afferent Pharmaceuticals.
KENILWORTH, N.J.--(BUSINESS WIRE)--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.