Merck (MRK) Receives CRL for Gefapixant
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Merck Provides U.S. Regulatory Update on Gefapixant
December 20, 2023 4:30 PM ESTRAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Mercks New Drug Application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. In the CRL, the FDA concluded that Mercks application did not meet substantial evidence of effectiveness for treating... More
