Merck's Gefapixant Under FDA Lens: Advisory Committee To Discuss Chronic Cough Drug's Future
Portfolio Pulse from Vandana Singh
The FDA's Pulmonary-Allergy Drugs Advisory Committee is set to review Merck & Co's (NYSE:MRK) gefapixant, a drug for chronic cough. The FDA previously declined approval due to concerns after Merck submitted additional efficacy data. The drug has been approved in the EU and Japan. FDA documents show gefapixant's modest efficacy and high discontinuation rates due to taste-related side effects. The committee will discuss if the benefits are clinically meaningful. MRK shares are slightly down.
November 16, 2023 | 5:26 pm
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Merck's gefapixant faces FDA scrutiny over its clinical benefits for chronic cough. Previous non-approval and concerns about efficacy and side effects may affect investor sentiment.
The FDA's upcoming review of gefapixant could result in continued non-approval, which would likely have a negative impact on Merck's stock in the short term. The previous decline to approve and the concerns about the drug's efficacy and side effects are critical factors that could dampen investor confidence.
CONFIDENCE 80
IMPORTANCE 75
RELEVANCE 100