FDA Panel Endorses COVID-19 Pill

A panel of experts gathered by the Food and Drug Administration on Tuesday narrowly endorsed drugmaker Merck’s COVID-19 antiviral pill, moving the drug a step closer to becoming the first pill authorized by the agency to treat the coronavirus.

The panel voted 13-10 that the pill’s benefits outweighed its risks when used to treat mild to moderate COVID-19 in adults who are at high risk for severe disease when taken within five days of symptoms. While the FDA doesn’t have to follow the group’s recommendations, it usually does.

Many members of the FDA’s Antimicrobial Drugs Advisory Committee wanted more safety data for the pill and cited concerns about pregnant people taking the drug. An FDA analysis of the medication said that studies suggest “molnupiravir may cause fetal harm when administered to pregnant individuals” after it caused toxicity and birth defects in rats.

Merck told the panel that it agreed that the drug should not be recommended for people who are pregnant but opposed restricting the drug in the group, saying the benefits could outweigh the risks in some scenarios. The company also said it is working to test how the drug stands up to the omicron variant.

The company originally reported that molnupiravir cut the risk of hospitalization and death from COVID-19 in half, but those numbers were revised down in later data. It’s updated results showed that the pill reduced the combined risk of hospitalization and death in high-risk, unvaccinated people by 30%.

The pill seems to be substantially less effective than a similar drug from Pfizer that is also under review by the FDA.

Cutting the risk of severe COVID-19 with a pill that can be taken at home could help keep hospitals from getting overwhelmed with coronavirus patients. Merck’s pill is already authorized for emergency use in Britain.

Merck previously said that it expects to produce 10 million courses of the treatment by the end of the year. The U.S. government has agreed to buy about 3.1 million courses of the drug for approximately $2.2 billion, pending FDA emergency use authorization.