FDA declines to approve Merck's chronic cough drug

 The U.S. Food and Drug Administration (FDA) has declined to approve Merck's drug for chronic cough, the company said on Wednesday, marking the second rejection in less than two years. The health regulator concluded that the company's application for the drug, gefapixant, did not meet substantial evidence of effectiveness for treating refractory chronic cough and unexplained chronic cough. In November, the agency's advisory committee panel voted 12 to 1 against the late-stage data submitted for the drug, on concerns over how well it works. The FDA's decision was not related to the drug's safety, Merck said, adding that it is reviewing the agency's feedback to determine next steps. There is no approved treatment for refractory or unexplained chronic cough or coughing bouts that don't go away despite treatment of underlying conditions or have no identifiable cause.

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