FDA Expert Panel to Determine the Efficacy of Merck's Chronic Cough Medication

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Published on November 17, 2023 - Duration: 01:30s

FDA Expert Panel to Determine the Efficacy of Merck's Chronic Cough Medication

FDA Expert Panel to , Determine the Efficacy of , Merck's Chronic Cough Medication.

FDA Expert Panel to , Determine the Efficacy of , Merck's Chronic Cough Medication.

On November 15, health regulators in the United States flagged concerns that Merck's chronic cough drug, gefapixant, may not have a meaningful benefit.

On November 15, health regulators in the United States flagged concerns that Merck's chronic cough drug, gefapixant, may not have a meaningful benefit.

Reuters reports that the concerns were listed in documents released ahead of a meeting of independent experts.

In afternoon trading, Merck shares were down almost 1%, coming in at $101.2.

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Concerns were raised after additional efficacy data was submitted by the company to the U.S. Food and Drug Administration (FDA).

Concerns were raised after additional efficacy data was submitted by the company to the U.S. Food and Drug Administration (FDA).

In January of last year, the FDA declined to approve the drug.

The FDA's expert panel of advisers is set to meet on November 17 to discuss the data provided by Merck and determine the efficacy of gefapixant.

Reuters reports that the panel will determine whether the small reduction in cough frequency that comes with the drug is clinically meaningful enough to be approved.

Reuters reports that the panel will determine whether the small reduction in cough frequency that comes with the drug is clinically meaningful enough to be approved.

Chronic cough impacts about 10% of the world's adult population, with about half of those individuals not having an identifiable cause for the cough despite testing.

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Merck's gefapixant blocks receptors that stimulate nerves which trigger a cough.

In the European Union and Japan, the drug has been approved to treat chronic coughing and is sold under the brand name Lyfnua


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