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.
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.
At its 17 November meeting, the panel voted 12-1 that there is insufficient evidence of a clinically meaningful benefit for...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
