FDA Panel Gives Limited Support for First Merck-made COVID-19 Antiviral Pill

WASHINGTON (AP) – A group of U.S. medical advisers on Tuesday staunchly advocated Merck .’s COVID-19 drug, setting the stage for the first drug Americans can use at home to treat coronavirus.

A panel of the Food and Drug Administration (FDA) voted October 13 that the benefits of the drug outweigh its risks, including potential birth defects if used. during pregnancy. The recommendation comes after hours of debate over the drug’s modest benefits and potential safety issues. Experts in favor of the treatment stress that it should not be used by anyone who is pregnant and urge the FDA to recommend additional precautions before the drug is prescribed, including tests. pregnancy test for women of childbearing age.
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The vote specifically in favor of this drug is for adults with mild to moderate COVID-19 who face the greatest risks, including older adults and people with other medical conditions. diseases such as obesity and asthma. Most experts also say the drug should not be used in vaccinated patients who were not part of the study and have not been 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 pill has been authorized in the UK

The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes the number of cases higher and US officials brace for the arrival of the virus. new omicron variant. Merck has not specifically tested its drug against the new variant but said it will have some effectiveness based on effectiveness against other strains of coronavirus. But that uncertainty frustrated many of the panelists as they grapple with whether to support treatment for millions of Americans.

“There is no data that says it works with new variation I really think we need to be careful when we say this is the way to go,” said Dr David Hardy of the Charles Drew University School of Medicine and Science, who ultimately voted in favor of the drug for know.

The panel’s narrow but positive recommendation comes despite new data from Merck that paint a less convincing picture of the drug’s effectiveness than it did just a few weeks earlier. Last week, Merck said final study results showed that molnupiravir reduced hospitalization and death rates by 30% in adults with coronavirus, when compared with adults taking a placebo. That effect is significantly less than the 50% reduction first published based on incomplete results.

That smaller-than-expected benefit has raised concerns among experts about the drug’s toxicity to the fetus. FDA scientists told panelists earlier on Tuesday that the company’s studies in rats have shown the drug to cause toxicity and birth defects when used in very high doses. high. Taken together, FDA staff members concluded the data “suggests that molnupiravir may cause fetal harm when administered to a pregnant woman.”

The FDA is considering mass-restricting any use in pregnant women or allowing it in rare cases. Several panelists said this option should be left open to pregnant mothers who are at high risk for COVID-19 and may have few other treatment options. Dr Janet Cragan, an advocate for the drug, says that even with tight restrictions, some pregnant women will inevitably take the drug. “I don’t think you can morally say to a woman with COVID-19 that she can’t have the medication if she decides it’s what she needs,” said a panel member and staff member. of the Centers for Disease Control and Prevention. “I think the final decision should be with each woman and her carers.”

Merck’s drug uses a new approach to fight COVID-19: It inserts small errors into the coronavirus’ genetic code to prevent it from reproducing. That genetic effect has raised concerns that the drug could promote more virulent strains of the virus. But FDA regulators said Tuesday that the risk is theoretical and appears unlikely.

While Merck and partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is behind with its own pill under review. Pfizer’s Pills are part of a decades-old line of antiviral drugs called protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently from Merck’s drugs and are not linked. regarding the type of mutation presented with Merck’s drug.

Pfizer this week said its drug is not affected by mutations in the omicron variant. The US government has agreed to buy 10 million courses of Pfizer’s drug, if authorized. This is more than triple the government’s purchase agreement with Merck for 3.1 million packs of molnupiravir. Both of these drugs require the patient to take several pills, twice a day for five days.

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

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