FDA to Review Merck’s COVID-19 Vaxx: Bloomberg



The U.S. Food and Drug Administration will send drugmaker Merck & Co’s experimental COVID-19 antiviral drug to a panel of its outside advisers for a review, Bloomberg News reported on Thursday, citing a person familiar with the plans.

The advisory committee will weigh in on molnupiravir’s safety concerns, which have been raised by some experts, before the FDA makes a decision on authorization of the drug, the report said.

Merck earlier this week said it filed for U.S. emergency use authorization for molnupiravir to treat mild-to-moderate patients of COVID-19, putting it on course to become the first oral antiviral medication for the disease.

Merck, Pfizer, Roche — All in Race for a Pill

Pfizer Inc and Swiss drugmaker Roche Holding AG are also racing to develop an easy-to-administer antiviral pill for COVID-19.

Merck is developing molnupiravir in partnership with U.S.-based Ridgeback Biotherapeutics.

In early October, data showed Merck’s drug could halve the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19, pummeling shares of coronavirus vaccine makers.

The FDA and Merck did not immediately respond to Reuters’ requests for comment.


© 2021 Thomson/Reuters. All rights reserved.



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