FDA will review Merck’s Covid treatment “as soon as possible”

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The White House’s chief medical adviser, Dr. Anthony Fauci, said on Friday that the U.S. Food and Drug Administration will review relevant Merck And Ridgeback Biotherapeutics’ new Covid oral antiviral drug “as soon as possible”, hoping to obtain emergency use authorization.

Company representation Their antiviral drugs Monelavir treatment reduces the risk of hospitalization or death for unvaccinated mild or moderate Covid patients by approximately 50%. In the Phase III clinical trial, 775 trial participants taking monelavir or placebo were recruited, and 8 people taking placebo died within 29 days. According to data released on Friday, none of the participants who took monelavir died.

“You must make sure to give the FDA time to review the data very carefully and make an emergency use authorization decision,” Fauci told CNBC.Closed bell.” “So I don’t want to surpass them. I can’t predict when it will happen, but I can tell you one thing: they will do it as soon as possible. ”

Merck and Ridgeback Biotherapeutics also stated that in their phase 3 study, 7.3% of monopiravir recipients were hospitalized within 29 days, while 14.1% of placebo recipients were hospitalized or died. All participants have at least one health condition, which increases their chance of developing more severe Covid symptoms.

The FDA’s emergency use authorization will make molnupiravir the first oral antiviral drug to fight Covid. The United States has agreed to purchase 1.7 million courses of monupiravir. The White House coronavirus response coordinator Jeff Zients told reporters at a briefing on Friday that if the drug is approved, the government can choose to purchase more doses.

Merck expects that by the end of 2021, there will be 10 million monopvir treatments.

When asked whether molnupiravir will eventually be used exclusively for people who have not been vaccinated, Fauci said he wanted to avoid speculation before the FDA makes a final decision.People who are fully vaccinated can still be infected with Covid, especially As the vaccine’s effectiveness diminishes, But they retain a high degree of protection against serious illness and death.

Fauci said: “I shouldn’t get the FDA authorization in advance.” “But I will assume that if you are infected, you are infected. It doesn’t matter whether you have been vaccinated or not.”

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