The US Food and Drug Administration on Thursday authorized Merck’s antiviral pill, molnupiravir, to treat Covid-19.
This is the second Covid-19 antiviral pill authorized for ill people to take at home, before they get sick enough to be hospitalized. Merck has an agreement with the US government for the company to supply 3.1 million courses of molnupiravir upon this authorization.
An FDA news release said the pill is authorized “for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.”
Molnupiravir was narrowly recommended by the FDA’s advisers in a 13-10 vote at the end of November after data showed it cut the risk of hospitalization or death by 30% among high-risk adults. This was lower than an earlier analysis suggesting that number could be about 50%.
Dr. Eliav Barr, senior vice president of global medical affairs at Merck, told CNN this month that he was optimistic this treatment would work against the Omicron variant.
“The Omicron variant is primarily different from the other types of Covid at the spike protein. Our drug works in completely different part of the virus. So we’re very optimistic that the drug will continue to be effective against Omicron, and we’re studying that right now.”
Pfizer pill: On Wednesday, the FDA authorized Pfizer’s antiviral pill, Paxlovid, to treat Covid-19, the first antiviral Covid-19 pill authorized in the US for ill people to take at home, before they get sick enough to be hospitalized. High-risk individuals age 12 and older who weigh at least 88 pounds and have a positive SARS-CoV-2 test are eligible for this treatment and will need to have it prescribed by a doctor.
The pill “should be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset,” according to an FDA statement.
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