Merck & Co shares dented by gefapixant CRL

25 January 2022

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.

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