FDA Panel Rejects Merck’s Gefapixant For Chronic Cough, Calls For Better Endpoints
Executive Summary
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.
You may also be interested in...
Keeping Track: US FDA Drugs Center Passes 50 Novel Agent Approvals In 2023
AstraZeneca’s Truqap and Evive’s Ryzneuta bring FDA center for drugs’ 2023 novel agent total to 51, while biologics center already sits on a record-breaking 14 novel approvals.
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.
The History Behind The Drug-Device Combos Targeted By FTC
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.