FDA panel narrowly backs COVID-19 pill from Merck

Updated: 3:54 p.m. on Nov. 30, 2021

By MATTHEW PERRONE AP Health Writer

WASHINGTON (AP) — U.S. health advisers have narrowly endorsed an antiviral drug from Merck to treat COVID-19.

It sets the stage for an expected authorization of the first pill that Americans could take at home for the coronavirus.

A Food and Drug Administration panel voted Tuesday that the drug's benefits outweigh its risks, including potential birth defects if used during pregnancy.

The FDA isn't bound by the panel's recommendation and is expected to make its own decision before the end of the year.

Merck's pill could provide a much-needed therapy as cases rise in number and U.S. officials brace for the arrival of the new omicron variant.


Posted: 8:26 a.m. on Nov. 30, 2021

By MATTHEW PERRONE AP Health Writer

WASHINGTON (AP) — U.S. health advisers are reviewing Merck's closely watched COVID-19 pill, which could become the first easy-to-use drug for American patients.

The Food and Drug Administration asked its outside experts Tuesday whether the agency should authorize the pill. They will weigh new data that the pill is less effective than the company first reported.

Merck said last week that final study results showed its pill reduced hospitalization and death by 30%, lower than the 50% reduction it first announced last month. The FDA panel will take that smaller benefit into consideration as it reviews the drug.

FDA regulators will make its final ruling on the drug following the meeting.

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