Merck's Gefapixant CRL Dashes Hopes For Another Near-Term Growth Driver

Jan 24 2022

• By Jessica Merrill

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The US FDA issued a complete response letter for the P2X3 receptor antagonist for the treatment of refractory chronic cough, requesting more efficacy data.

rejection — Merck received a CRL from FDA • Source: Alamy

Merck & Co., Inc. is facing another setback in its efforts to diversify its revenue stream outside of Keytruda (pembrolizumab) with a complete response letter for its P2X3 receptor antagonist gefapixant from the US Food and Drug Administration, which means Merck is losing out on an early 2022 launch for the treatment of refractory chronic cough (RCC). The company announced receipt of the CRL on 24 January.

While Merck has been optimistic about the outlook for the first drug to reach the market for chronic cough, analysts...

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