Merck Covid pill narrowly backed by US FDA advisers

Decision paves way for US authorisation of molnupiravir, the at-home drug treatment for virus

A panel of US health advisers narrowly backed Merck's Covid-19 pill, paving the way for the at-home treatment to be authorised. Handout via Reuters

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A panel of US health advisers on Tuesday narrowly backed the benefits of a closely watched Covid-19 pill from Merck, setting the stage for a likely authorisation of the first drug that Americans could take at home to treat the virus.

A US Food and Drug Administration panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy.

The group’s recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed it should not be used by pregnant women and called on FDA to recommend extra precautions, including pregnancy tests for women before using the drug.

The group’s vote specifically 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 FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end.

FDA authorization for the drug, molnupiravir, could be a major step in treating the virus. It would give doctors the first drug they could prescribe for patients to take on their own, easing the burden on hospitals and helping to curb deaths.

The pill is already authorised in the UK.

Merck scientists said they believe their drug will be effective against the new Omicron variant. They said the drug worked against other variants, including the prevailing Delta strain.

Merck tested the drug in adults with mild-to-moderate Covid-19 who were considered higher risk due to health problems like obesity, diabetes or heart disease. That’s the same group that currently receives antibody drugs, which help the immune system fight the virus. The US FDA has authorized three antibody drugs for Covid-19 but all have to given by IV or injection at hospitals or clinics.

Merck was the first company to submit its Covid-19 pill to the US FDA, but a rival drug from Pfizer is close behind and is also under review.

Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations.

Updated: December 1st 2021, 8:34 AM