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FDA Refuses To Approve Merck's 'gefapixant' To Treat Chronic Cough

Merck & Co Inc. (MRK) on Tuesday said the FDA refused to approve its investigational drug, gefapixant for the treatment chronic cough and sought additional information related to the drug's efficacy.

The FDA issued a Complete Response Letter (CRL) regarding Merck's New Drug Application for gefapixant for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults, Merck said.

"We remain committed to advancing gefapixant for patients with refractory or unexplained chronic cough and will work with the FDA to address the agency's feedback," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Last week, the Japan Ministry of Health, Labor and Welfare had approved gefapixant, under the trade name LYFNUA, for adults with refractory or unexplained chronic cough.

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