FDA panel narrowly supports Merck’s first COVID-19 pill

WASHINGTON – A panel of U.S. health advisers narrowly backed the benefits of a closely watched COVID-19 pill from Merck on Tuesday, paving the way for a likely clearance of the first drug Americans could take at home to treat the virus .

A Food and Drug Administration panel voted 13 in 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 over the drug’s modest benefits and potential safety concerns. Experts supporting the treatment stressed that it should not be used by anyone who is pregnant and asked the FDA to recommend additional precautions before the drug is prescribed, including pregnancy tests for women of age. procreate.

The vote specifically supported the drug for adults with mild to moderate COVID-19 who face the greatest risks, including the elderly and those with conditions such as obesity and asthma. Most experts also said the drug should not be used in vaccinated patients, who were not in the study and were not shown to benefit.

The FDA is not bound by the panel’s recommendation and is expected to make its own decision before the end of the year.

The drug, molnupiravir, could provide a much needed weapon against the virus as colder weather increases the number of cases and US officials prepare for the arrival of the new omicron variant. It is already authorized for emergency use.

Merck has not 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 questioned whether to support treatment for millions of Americans.

“With no data to indicate that it works with newer variants, I really think we have to be careful not to say this is the way to go,” said Dr David Hardy of Charles Drew University School. of Medicine and Science, which ultimately voted to support the drug.

The panel’s narrow but positive recommendation came despite new data from Merck which paints a less convincing picture of the drug’s effectiveness than a few weeks earlier.

Last week, Merck said final study results showed molnupiravir reduced hospitalizations and deaths by 30% in adults infected with the coronavirus, compared to adults taking a placebo. This effect was significantly lower than the 50% reduction initially reported based on incomplete results.

This smaller-than-expected benefit amplified experts’ concerns about the drug’s toxicity to human fetuses.

FDA scientists told panelists on Tuesday that the company’s studies in rats had shown the drug to cause toxicity and birth defects when given in very high doses. Taken together, FDA staff members concluded that the data “suggests that molnupiravir may cause fetal harm when given to pregnant people.”

The FDA weighs a general restriction against any use in pregnant women or allows it in rare cases. Some panelists said the option should be left open to pregnant women who have high-risk COVID-19 and may have few other treatment options.

Dr Janet Cragan, who has supported the drug, said that even with strict restrictions, some pregnant women would inevitably take the drug.

“I don’t think you can morally tell a woman with COVID-19 that she can’t take the drug if she decides it’s what she needs,” a panel member and staff member at Centers for Disease Control and Prevention. “I think the final decision should be with the woman and her provider.”

Merck’s drug uses a new approach to tackle COVID-19: it inserts tiny errors into the genetic code of the coronavirus to prevent it from reproducing. This genetic effect has raised concerns that the drug will stimulate more virulent strains of the virus. But FDA regulators said Tuesday the risk is moot and seems unlikely.

While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is closely behind with its own pill under review.

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 from the Merck pill and don’t have not been linked to the type of mutation issues raised with the Merck drug.

Pfizer said this week that its drug should not be affected by mutations in the omicron variant.

The US government has agreed to buy 10 million treatments of the drug from Pfizer, if it is licensed. That’s more than three times the government’s purchase agreement with Merck for 3.1 million courses of molnupiravir.

Both drugs require patients to take several tablets, twice a day for five days.

The Associated Press’s Department of Health and Science receives support from the Department of Science Education at Howard Hughes Medical Institute. The AP is solely responsible for all content.

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