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FDA Advisors Recommend Authorizing First Antiviral Pill To Treat Covid

A Food and Drug Administration advisory group voted 13-10 to approve the first antiviral pill to treat adults at high risk for severe disease from Covid-19, among the first oral antiviral drugs that could serve as key to stave off the public health crisis, as the United States braces for the emergence of the omicron variant.

The drug developed by Merck and Ridgeback Biotherapeutics – molnupiravir – is a five-day pill regimen to be used at home within five days of symptom onset, potentially relieving overburdened hospitals.

Last week, Merck announced that the drug reduced the risk of hospitalization or death by approximately 30% in patients with mild to moderate symptoms of Covid-19.

The FDA is not bound by the divisional vote of November 30, although the agency generally supports the recommendations of its outside advisers.

Merck has pledged to produce enough pills to treat 10 million patients by the end of the year, and the U.S. government has ordered enough drugs to treat more than 3 million people.

“With the continued spread of the virus and the emergence of variants, additional treatments for Covid-19 are urgently needed,” said Dr Dean Y Li, executive vice president and chairman of Merck Research Laboratories. “This is why we are acting quickly and rigorously to obtain authorizations and accelerate wide global access to this investigational drug. “

The advisory group’s recommendation comes as U.S. health officials expand their search for the latest variant, which has yet to be detected in the country.

Omicron carries a worrying number of mutations in a “spike” protein that attaches to human cells, raising concerns among health officials that the variant may be more transmissible and test the effectiveness of current vaccines.

The pills do not target the spike protein; they weaken two proteins involved in the virus’s ability to replicate. Omicron would carry only one mutation in each of these proteins. Merck has argued that its drug has the potential to work against new variants, and the company is working to determine how resistant it is to omicron.

Another oral pill regimen, developed by Pfizer that may be more effective than Merck’s regimen, is also under review by the FDA.

Dr Rochelle Walensky, director of the Centers for Disease Control and Prevention, told reporters on Tuesday that the agency “is actively researching” the presence of the new variant in the United States; the delta variant remains the dominant variant in the United States, accounting for about 99% of new cases.

On November 29, President Joe Biden sought to bring calm after the emergence of the omicron, telling Americans in a speech to the White House on Monday that the variant is “a cause for concern, not a cause. of panic “.

“We’re going to fight and beat this new variant as well,” he said. “The best protection (…) is to get fully vaccinated and get a booster,” he said.

White House medical adviser Dr Anthony Fauci said it would likely take up to two weeks to learn more about the variant, including its vaccine response, transmissibility and health impacts.

“We shouldn’t panic,” he told CBS. “We should be doing the things we know to work when you are dealing with a pandemic virus. Now is not the time to panic.

He added, “We should be worried, and our worry should make us do the things that we know are working. “

The Independent Gt

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