The U.S. Food and Drug Administration on Thursday authorized Merck & Co’s antiviral pill for COVID-19 for certain high-risk adult patients. The news comes a day after the FDA gave the go-ahead to a similar treatment from Pfizer Inc for high-risk patients above the age of 12.
Molnupiravir’s emergency approval was supported by a clinical trial comparing 709 COVID patients who got the drug to 699 patients who received a placebo.
About 6.8% of people who got molnupiravir were hospitalized or died during a month of follow-up, compared to 9.7% of people who received a placebo, the FDA said. That includes one patient given molnupiravir who died, compared with nine placebo patients who died.
Merck’s drug, molnupiravir, developed with Ridgeback Biotherapeutics, reduced hospitalizations and deaths by around 30% in a clinical trial of high-risk individuals early in the course of the illness.
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Much like with Pfizer’s pill, the agency authorized the oral drug for the treatment of mild-to-moderate COVID-19 in adults who are at risk for severe disease, and for whom alternative COVID-19 treatments are not accessible or clinically appropriate.
The decision follows a narrow vote in favor of authorization by a panel of advisers to the FDA on Nov 30.
How will an oral pill help?
Both the Merck and Pfizer pills could be promising tools for those who are sick with COVID-19, as the holidays approach and the fast-spreading Omicron variant becomes the dominant variant in the United States accounting for 73% of new COVID cases.
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“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,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research says.
Comparing the two drugs
The drug is not authorized for use in patients younger than 18 because molnupiravir may affect bone and cartilage growth, the FDA said. However, Pfizer’s drug was authorized on Wednesday for people aged 12 and older.
Pfizer’s antiviral regimen, Paxlovid, was nearly 90% effective in preventing
