FDA Panel Narrowly Votes To Recommend Merck's COVID-19 Pill
PHILADELPHIA (CBS) -- Merck is closer to getting authorization for its COVID pill. It's the first drug Americans could take at home to treat the coronavirus.
An FDA advisory panel has voted to recommend that the FDA and CDC authorize the use of an antiviral pill to treat the worst effects of COVID-19 in high-risk patients.
The FDA's Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of pharmaceutical giant Merck's antiviral pill, which is called molnupiravir.
The pill has been shown to modestly reduce the risk of hospitalization and death from COVID.
But, that close vote speaks to the hesitancy and outstanding questions which remain about its use, mainly, that its efficacy isn't overwhelmingly good.
In a statement on their website this evening after the vote, Merck wrote, "The positive outcome of today's FDA advisory committee meeting, following a comprehensive review of molnupiravir demonstrating a significant reduction in hospitalizations and deaths is a critical step toward bringing this promising oral medicine for COVID-19 to appropriate patients in the U.S. With the continued spread of the virus and the emergence of variants, additional treatments for COVID-19 are urgently needed."
Merck's trials mostly enrolled people infected with the delta, mu and gamma variants of the coronavirus. No experiments have been run to test its efficacy against the new omicron variant.
If authorized by the FDA and CDC, this pill could be available for Americans to use in a matter of weeks.
CBS3's Siafa Lewis reports.