People who suffer from chronic cough may be offered new hope thanks to a drug that can ease the symptom. Researchers suggest the medication called gefapixant ha.
People who suffer from chronic cough may be offered new hope thanks to a drug that can ease the symptom. Researchers suggest the medication called gefapixant ha.
By Colin Kellaher Merck & Co. on Monday said the U.S. Food and Drug Administration has turned away the drugmaker s application seeking approval of gefapixant for the treatment of. | January 24, 2022
Merck is still at the front of the pack of companies developing new medicines to treat chronic cough, but the company was dealt a setback as the FDA turned down the pharma giant’s application and asked for additional efficacy data. No safety issues were raised, according to Merck.
Merck: FDA To Review NDA For Gefapixant
KENILWORTH (NJ) (dpa-AFX) - Merck (MRK) said the FDA has accepted for review the company s New Drug Application for gefapixant, an orally administered, selective P2X3 receptor antagonist, for the treatment of refractory chronic cough or unexplained chronic cough in adults. The FDA has set a PDUFA, or target action date, of Dec. 21, 2021.
Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said: If approved by the FDA, gefapixant would be the first medicine approved specifically to help these patients, and we look forward to participating in the advisory committee meeting and working with the FDA as they review our application.