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
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