FDA accepts gefapixant for review in cough, positioning Merck to get head start on Bayer and Bellus

FDA accepts gefapixant for review in cough, positioning Merck to get head start on Bayer and Bellus

Source: 
Fierce Biotech
snippet: 

The FDA has accepted a filing for approval of Merck’s P2X3 receptor antagonist gefapixant for review. Merck is seeking approval on the basis of phase 3 trials that linked the oral drug to improvements in several measures of chronic cough symptoms but confirmed tolerability concerns.

Gefapixant is at the front of a pack of P2X3 prospects in development at companies including Bayer, Bellus Health and Shionogi. Merck validated the target last year in a pair of phase 3 trials, COUGH-1 and COUGH-2, that found gefapixant drove relative risk reduction in 24-hour coughs per hour. Yet, 15% to 20% of subjects on the high dose dropped out due to adverse events.