FDA Panel Narrowly Backs a First-of-a-Kind COVID-19 Antiviral Pill Made By Merck

WASHINGTON (AP) — A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus.

A Food and Drug Administration (FDA) panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. The recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Supporters of the treatment insisted that the drug should not be prescribed to pregnant women. They also requested FDA to provide additional precautions such as pregnancy tests for those who are expecting.
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It was specifically approved for people suffering from moderate-to-severe COVID-19. These are the most vulnerable, and include older persons and those who have conditions like asthma and obesity. 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. The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end. In the U.K., the pill has been approved.

As colder weather drives case counts up and U.S. authorities prepare for the arrivals of the next omicron type, the drug molnupiravir may be an effective weapon in fighting the virus. 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. Many panelists were frustrated by this uncertainty as they debated whether or not to support the treatment for millions upon millions of Americans.

“With no data saying it works with new variants I really think we need to be careful 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 picture of the drug’s effectiveness than just a few weeks earlier. Merck announced last week that molnupiravir had reduced death and hospitalization rates by 30% in coronavirus-infected adults compared to adults who received a placebo. The 50% reduction that Merck initially announced was much lower than what it actually achieved based only on partial results.

That smaller-than-expected benefit amplified experts’ concerns about the drug’s toxicity for fetuses. Scientists from FDA told panelists Tuesday earlier that studies by the company in rats had shown the drug could cause toxicity and birth defects if given very high doses. Taken together, FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.”

FDA considers whether it should place restrictions on the use of this drug in all pregnant women, or allow it to be used in very limited cases. Panelists suggested that pregnant women with high-risk COVID-19 should have the option to continue using it even if they have no other options. Janet Cragan supported the drug and said that the drug would be taken by pregnant women regardless of strict restrictions. “I don’t think you can ethically tell a woman with COVID-19 that she can’t have the drug if she’s decided that’s what she needs,” a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.”

Merck’s drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus’ genetic code to stop it from reproducing. The drug’s genetic effects have raised fears that it might lead to even more deadly strains. FDA officials stated Tuesday that there is no risk and it seems unlikely.

Merck and Ridgeback Biotherapeutics, its associate, were the first drugmakers to submit the COVID-19 pills to FDA. However Pfizer, a rival drugmaker is following closely with its submission. Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns raised with Merck’s drug.

Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations. The U.S. government has agreed to purchase 10 million treatment courses of Pfizer’s drug, if it’s authorized. That’s more than three times the government’s purchase agreement with Merck for 3.1 million courses of molnupiravir. Each drug requires patients to take several pills twice daily for five consecutive days.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. All content remains the responsibility of the Associated Press.


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