FDA panel backs COVID-19 pill from Merck

A panel of U.S.

WASHINGTON — health advisers on Tuesday narrowly backed the benefits of a closely watched COVID19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the virus.

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

The group’s recommendation came after hours of debate about the drug’s modest bene- fits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is preg- nant and called on FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age.

The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn’t be used in vaccinated patients, who weren’t part of the study

and haven’t been shown to benefit from the medication.

The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end. The pill is already authorized in the U.K.

The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and U.S. officials brace for the arrival of the new omicron variant. It is already authorized for emergency use.

Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of coronavirus.

But that uncertainty frustrated many panelists as they grappled with whether to back the treatment.

“With no data saying it works with new variants I really think we need to be care- ful about saying that this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine

and Science, who ultimately voted to back the drug.

The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling pic- ture of the drug’s effectiveness than just a few weeks earlier.

Last week, Merck said final study results showed mol- nupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. That effect was significantly less than the 50% reduction it first announced based on incom- plete results.

That smaller-than-expected benefit amplified experts’ con- cerns about the drug’s toxic- ity for human fetuses.

FDA scientists told the pan- elists earlier Tuesday that company studies in rats showed the drug caused toxicity and birth defects when given at very high doses. Taken together, FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant indi

viduals.”

FDA is weighing a blanket restriction against any use in pregnant women or allowing it in rare cases. Some panelists said the option should be left open for pregnant mothers who have high-risk COVID-19

and may have few other treatment options.

Dr. Ja n et Cragan, who backed the drug, said that even with tight restrictions some pregnant women would inevitably take the drug.

“I don’t think you can ethically tell a woman with COVID19 that she can’t have the drug if she’s decided that’s what she needs,” a panel member said.