Posted by Michael Wonder on 01 Mar 2021
US FDA accepts Merck’s gefapixant new drug application for review
1 March 2021 - Application for orally administered selective P2X3 receptor antagonist based on findings from two Phase 3 trials in patients with refractory or unexplained chronic cough.
Merck announced today that the US FDA has accepted for review the company’s new drug application for gefapixant, an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory chronic cough or unexplained chronic cough in adults.
This application for gefapixant will be discussed at an upcoming advisory committee meeting. No date has been set yet. The FDA has set a Prescription Drug User Fee Act, or target action date, of 21 December 2021.
