FDA authorizes second COVID-19 antiviral pill, Merck’s molnupiravir

One day after the U.S. Food and Drug Administration (FDA) granted emergency use authorization to Pfizer’s COVID-19 antiviral pill, Paxlovid, the agency on Thursday granted the same emergency use authorization to Merck’s antiviral medication, molnupiravir.

Both pills are intended only for people who are at high risk for hospitalization and death from severe COVID, and they are available by prescription only.

“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in an agency statement.

“As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness,” she said.

Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating. Molnupiravir is administered as four 200 milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules. Molnupiravir is not authorized for use for longer than five consecutive days.

A Merck spokesperson said Merck is ready to ship hundreds of thousands of courses of treatment within days of authorization and 1 million courses over the next few weeks in the U.S. Ten million courses are ready to be packaged and distributed worldwide.

Data on molnupiravir has shown its potential could be limited. Initial results from a study showed it reduced hospitalizations by 50% — but that figure was revised downward to 30% after full data were released.

In contrast, Pfizer’s drug, Paxlovid, was shown in studies to reduce hospitalizations by nearly 90 percent.


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