Merck Reports the US FDA’s Acceptance of NDA for Review of Gefapixant to Treat Refractory or Unexplained Chronic Cough

March 2, 2021 Auto Bot Acceptance, FDA, Gefapixant, Merck, NDA, regulatory, reports, Review 0

Shots:

  • The NDA submission is based on two P-III studies (COUGH-1 & -2) involves assessing gefapixant (45/15mg, bid) vs PBO in 2,044 patients with RCC & UCC
  • In both the studies, gefapixant resulted in the reduction of in 24hrs.-cough frequency @12 & 24wks respectively. Data were presented at ERS 2020
  • Gefapixant is a selective P2X3 receptor antagonist for the potential treatment of refractory or unexplained chronic cough. The anticipated PDUFA date is Dec 21, 2021

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: The Morning Call

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