Merck cough drug fails to win adcomm’s backing as FDA raises efficacy questions
The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 12 to 1 in support of rejecting Merck’s application for its chronic cough drug gefapixant, following agency concerns over the drug’s efficacy data.
The panel of outside advisors voted on whether Merck’s data showed gefapixant had a clinically meaningful benefit. In the run-up to the session, FDA staff had cited what they called a small reduction in coughing frequency, and results from secondary endpoints that they described as “not statistically persuasive.”
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