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.
Merck & Co., Inc.’s gefapixant may have difficulty winning the support of an advisory committee given its limited effect in reducing chronic cough, but the lack of any approved treatment for the condition may give it an edge.
The US Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee is to consider the evidence of effectiveness for gefapixant, an...
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.
