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FDA panel backs first-of-a-kind COVID-19 pill from Merck | News – Atlanta, Georgia

Atlanta, Georgia 2021-11-30 17:14:00 –

Washington (AP) —A committee of US health advisors on Tuesday narrowly supports the benefits of the carefully watched COVID-19 pill from Merck, the first drug Americans can take at home to treat the virus. Ready for the possibility of approval.

A committee of the Food and Drug Administration voted 13-10 that the benefits of the drug outweigh its risks, including potential birth defects when used during pregnancy.

The group’s recommendations came after hours of discussion about the modest benefits of the drug and potential safety issues. Treatment-supporting experts emphasized that pregnant people should not be used and advised the FDA to recommend additional precautions before the drug is prescribed, including pregnancy tests for women of childbearing age. I asked.

The vote specifically favored drugs for adults with mild to moderate COVID-19 facing maximum risk, including the elderly and those with conditions such as obesity and asthma. Most experts also stated that this drug is not part of the study and should not be used for vaccinated patients who have not been shown to benefit from the drug.

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

The drug molnupiravir may provide a long-awaited weapon against the virus as the cold climate increases the number of cases and US authorities are preparing for the arrival of new Omicron variants. It is already licensed for emergency use.

Merck has not specifically tested the drug against new variants, but said it should have some efficacy based on its efficacy against other strains of coronavirus.

But that uncertainty has frustrated many panelists who have worked to support the treatment of millions of Americans.

“I think we need to be aware that this is the way to go, as we don’t have data to work with new variants,” said Dr. David Hardy of Charles Drew University School of Medicine. drag.

The narrow but positive recommendations of the panel came despite new data from Merck, which draws less convincing pictures of drug efficacy than just a few weeks ago.

Last week, Merck said the results of the final study showed a 30% reduction in hospitalization and mortality in adults infected with the coronavirus compared to adults taking placebo. The effect was significantly less than the 50% reduction initially announced based on incomplete results.

The smaller-than-expected benefits have exacerbated expert concerns about the toxicity of the drug to the human foetation.

FDA scientists told panelists early Tuesday that a company study in rats showed that the drug causes toxicity and birth defects when given at very high doses. In summary, FDA staff concluded that the data “suggest that molnupiravir can harm the foetation when administered to pregnant individuals.”

The FDA is considering or rarely allowing full restrictions on its use in pregnant women. Some panelists said this option should be left open to pregnant mothers who have high-risk COVID-19 and may have few other treatment options.

Dr. Janet Kragan, who supported the drug, said that even with strict restrictions, some pregnant women will inevitably take the drug.

“I don’t think we can ethically tell women with COVID-19 that they can’t take the drug if they decide it’s necessary,” said a panel member and staff member of the US Centers for Disease Control and Prevention. “I think the final decision must be left to the individual female and its donor.”

Merck’s medicine uses a new approach to combat COVID-19. Insert a small error in the genetic code of the coronavirus to prevent replication. Its genetic effects have raised concerns that the drug may spur more virulent strains of the virus. But FDA regulators said Tuesday that the risks are theoretical and unlikely.

Merck and its partner Ridgeback Biotherapeutics first submitted the COVID-19 pill to the FDA, but rival pharmaceutical company Pfizer is considering its own pill.

Pfizer’s drugs are part of a decade-old family of antiviral drugs known as protease inhibitors and are the standard treatment for HIV and hepatitis C. These work differently from Merck’s drugs and are not related to the types of mutation concerns caused by Merck’s drugs.

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

The US government has agreed to purchase 10 million treatment courses for Pfizer’s medication if approved. That’s more than three times the government’s purchase agreement with Merck for the 3.1 million courses at Molnupiravir.

With both drugs, the patient should take multiple tablets twice daily for 5 days.

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The Associated Press’s Department of Health Sciences is supported by the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.

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