US FDA Advisers To Review Merck’s Oral COVID-19 Drug Next Month By Reuters

(Reuters) – A panel of external advisers to the US health regulator will meet late next month to discuss whether to authorize Merck & Co’s experimental COVID-19 antiviral drug, the agency said Thursday.

The US Food and Drug Administration (FDA) panel will meet on November 30 to discuss the safety and effectiveness of the drug, molnupiravir, for the treatment of mild to moderate COVID-19 in adults who have tested positive and are at high risk for progression to serious disease. (https://refini.tv/3p1PETq)

The FDA generally follows the advice of its experts, but is not required to do so.

Merck said earlier this week that it applied for an emergency use authorization in the US for molnupiravir, which it is developing with its partner Ridgeback Biotherapeutics. The drug would become the first oral antiviral drug for COVID-19, if authorized by the agency.

Pfizer Inc (NYSE 🙂 and Swiss pharmaceutical company Roche Holding AG (OTC 🙂 are also competing to develop an easy-to-administer antiviral pill for the disease.

Merck’s treatment reduced the rate of hospitalization and death by 50% in a trial of mild-to-moderately ill patients who had at least one risk factor for the disease, according to data published earlier this month.

The company has a contract with the United States government to supply 1.7 million courses at a price of $ 700 per course. The pharmaceutical company also recently signed agreements with Malaysia and Singapore for the supply of the drug.

Bloomberg News first reported on a review of the drug by the US FDA’s advisory committee.

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