Washington (AP) —A committee of US health advisors on Tuesday narrowly supports the carefully monitored COVID-19 pill from Merck, the first drug Americans can take at home to treat the coronavirus. Ready for approval potential.
A committee of the Food and Drug Administration voted 13-10 that the benefits of antiviral drugs outweigh the risks, including potential birth defects when used during pregnancy.
“I think this is a very difficult decision with more questions than answers,” said Dr. Lindsey Baden of Harvard Medical School, who voted for the drug. He said the FDA must carefully coordinate drug use for the most profitable patients.
Recommendations came after hours of discussion about the modest benefits of the drug and potential safety issues. Most experts who support treatment emphasize that pregnant people should not use it and recommend additional precautions before the drug is prescribed, such as a pregnancy test for women of childbearing age. I asked for it.
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 said that the drug should not be used by vaccinated people who have not been shown to be beneficial and are not part of Merck’s research.
The FDA is not bound by the panel’s recommendations and is expected to make its own decisions by the end of the year.Antiviral agent Already approved In england
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.
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.
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. medicine.
On Friday, Merck released updated data that depict less convincing pictures of drug efficacy than just a few weeks ago.
Merck said Final research results Molnupiravir has been shown to reduce hospitalization and mortality in adults infected with the coronavirus by 30% compared to adults taking placebo.The effect was significantly less than the 50% reduction First announced Based on incomplete results.
For many panelists, the modest effect was not sufficient to outweigh the potential toxicity of the drug to the human foetation.
“Given the large potential population affected, the risk of widespread effects on potential birth defects has not been fully studied,” said the University of Utah School of Medicine, who voted against the drug. Dr. Sankar Swaminathan said.
FDA scientists told panelists early Tuesday that a company study in rats showed that the drug causes birth defects when given at very high doses. FDA staff concluded that the data “suggest that molnupiravir can harm the foetation when administered to pregnant individuals.”
Authorities are considering total restrictions on use in pregnant women or, in rare cases, allow doctors to use the drug. Some panelists said options should remain 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 antiviral drugs.
“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 Kragan, a panel member and staff member of the US Centers for Disease Control and Prevention. I am. “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. FDA regulators said on Tuesday that the risks were theoretical, but many panelists said they needed to be carefully tracked in follow-up.
Antiviral drugs have long been seen as significant advances beyond the antibody drugs currently in use. Antibody drugs should be injected or infused by a medical professional. However, given the shortcomings of Merck’s data, some experts have stated that patients prioritize receiving older medications.
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.
With both drugs, the patient should take multiple tablets twice daily for 5 days.
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.
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US Panel Supports Merck’s First COVID-19 Pill | News
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