The US Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee concluded that pivotal clinical trial data and patient-reported outcomes do not show that Merck & Co., Inc.’s gefapixant is effective in reducing chronic cough and recommended that the sponsor use different endpoints to determine whether it is beneficial.
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.
