CHMP endorses Merck’s gefapixant for EU approval for chronic cough treatment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist from Merck, also known as MSD outside the United States and Canada.

The drug is being developed for adults with refractory or unexplained chronic cough. The European Commission (EC) will now review the CHMP’s recommendation, with a final decision on EU marketing authorization expected later this year.

The CHMP’s positive opinion is based on the results from the COUGH-1 and COUGH-2 clinical trials, the first companion Phase 3 studies ever completed in patients with refractory or unexplained chronic cough. Both studies met the primary endpoint, showing a significant reduction in 24-hour cough frequency in adults treated with gefapixant 45 mg twice daily compared to placebo at 12 weeks (COUGH-1) and 24 weeks (COUGH-2).

“Today’s positive CHMP opinion is the next step for gefapixant to become the first treatment approved in the European Union for adults with refractory or unexplained chronic cough,” stated Dr Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories.

The COUGH-1 (NCT03449134) and COUGH-2 (NCT03449147) trials were multinational, randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of gefapixant in reducing cough frequency in adult participants with refractory chronic cough (RCC) or unexplained chronic cough (UCC). A total of 2,044 participants were involved in these studies.