FDA Panel Narrowly Approves Merck COVID-19 Pill
WASHINGTON — An advisory panel for the Food and Drug Administration narrowly approved the use of a COVID-19 pill manufactured by Merck.
If the agency accepts the recommendation, molnupiravir would be the first drug Americans could be prescribed and take at home to treat the virus.
The 13-10 vote by the panel came after an extended debate over the drug’s benefits and safety issues, such as the risk of birth defects if used during pregnancy.
In the end, the advisory panel said the drug should definitely not be used by pregnant women and should be labelled with extra safety precautions.
The panel backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including those with conditions like obesity, asthma and old age.
The pill is already authorized in the United Kingdom. Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo.
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