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FDA Panel Rejects Merck’s Gefapixant For Chronic Cough, Calls For Better Endpoints

 
• By Brenda Sandburg

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.

Coughing woman
Evidence does not support use of Merck's gefapixant for treatment of chronic cough, FDA advisory committee concludes • Source: Shutterstock

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.

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US FDA’s March Approval Candidates Take Aim At Established Markets

 
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‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
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