The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck & Co’s (NYSE: MRK) New Drug Application (NDA) for gefapixant, the orally administered selective P2X3 receptor antagonist, under development for refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.
Shares in the US pharma giant closed nearly 1.5% lower on Monday, when the news was announced.
"There are no available treatment options indicated in the USA specifically for this condition"In March 2021, Merck announced that the FDA accepted the company’s NDA for gefapixant. In the CRL, the FDA requested additional information related to measurement of efficacy.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze