FDA Panel Rejects Merck’s Gefapixant For Chronic Cough, Calls For Better Endpoints
Advisory committee votes 12-1 that data do not show the drug provides a meaningful clinical benefit. They suggest other endpoints than 24-hour cough frequency, such as reduction in bouts of coughing.
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Gefapixant 45 mg had a 15% to 17% relative reduction in 24-hour cough frequency compared to placebo from baseline to week 24 or week 12. Advisory committee to vote on whether this decrease along with results from patient-reported outcomes demonstrate a clinically meaningful benefit.
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