Merck Receives EMA’s CHMP Positive Opinion Recommending Approval of Gefapixant for Chronic Cough
Shots:
- The EMA’s CHMP has recommended the approval of gefapixant, a non-narcotic, oral selective P2X3 receptor antagonist for adults with refractory or unexplained chronic cough. The EC will review the CHMP’s recommendation for marketing authorization in the EU & a final decision is expected in 2023
- The opinion was based on the P-III (COUGH-1 & 2) trial results evaluating gefapixant vs PBO in 2044 patients. Both studies showed that adults treated with gefapixant (45mg, BID) achieved an 18.45% reduction in 24hr. cough frequency at 12wks. in (COUGH-1) while 14.64% in (COUGH-2) trial at 24wks.
- Gefapixant (15mg, BID) did not meet the primary efficacy EPs & results were published in The Lancet. Gefapixant was approved in Japan & Switzerland under the brand name Lyfnua for refractory or unexplained chronic cough
Ref: Merck | Image: Merck
Related News:- Merck Reports the US FDA's Acceptance of NDA for Review of Gefapixant to Treat Refractory or Unexplained Chronic Cough
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
