Merck Receives FDA Rejection for Gefapixant NDA Due to Insufficient Efficacy Evidence in Chronic Cough

MSD announced on December 20 local time that the U.S. Food and Drug Administration (FDA) had issued a response letter regarding the company's new drug application for gefapixant, which is under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC). The FDA determined that there was not substantial evidence of the drug’s efficacy in treating RCC and UCC. (Jiemian)Original link