The U.S. Food and Drug Administration issued an emergency use authorization on Thursday for Merck's molnupiravir pill, the second at-home COVID-19 treatment cleared.
Merck’s molnupiravir is intended for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression of the disease. It is available by prescription only and taken within five days of symptoms.
The FDA's authorization of Merck's molnupiravir comes a day after they authorized usage of Pfizer's Paxlovid pill for at-home COVID-19 treatment.
Molnupiravir is administered as four 200 milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules, and should not be taken longer than five consecutive days.
“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally," Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said. "Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death.
“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.”
The FDA did not authorize the use of molnupiravir in patients younger than 18-year-old because it may affect bone and cartilage growth. It is also not authorized for the pre-exposure or post-exposure prevention of COVID-19.
The pill should not be used as a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.
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