Merck’s Gefapixant: FDA Questions Whether Small Reduction In Chronic Cough Is Clinically Meaningful
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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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.
Keeping Track: Immunocore Wins Nod For First T-Cell Receptor Therapeutic; Veklury And Nucala Expand Settings Of Use; Merck & Co. Strikes Out In Chronic Cough
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Of the 16 products whose Orange Book patent listings have been challenged by the FTC, six have no generic competitors and two faced first generic launches this year. A review of their patent and pricing battles shows the difficulties in developing generics for these complex drugs.