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.
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.
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.
RELATED: Omicron Now Accounts for 73% of New COVID Cases
“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.
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
hospitalizations and deaths in patients at high risk of severe illness, according to trial data.
RELATED: FDA OKs Pfizer Pill as First At-Home COVID Treatment
Older people and those who have conditions like obesity, diabetes and heart disease would be eligible to get a prescription for Merck’s pills if they get sick from the coronavirus and cannot get treatments such as Pfizer’s newly authorized pills or monoclonal antibody treatments.
The pill is available to both vaccinated and unvaccinated people.
COVID patients would take four 200-milligram capsules at a time every 12 hours for five days, for a total of 40 capsules, the FDA said. The treatment will be available within a few weeks.
As with Paxlovid, patients should start their pill regimen as soon as possible after their COVID diagnosis, and within five days of symptom onset, according to the FDA.
Merck’s pill works by introducing errors into the virus’s genes to stop it from replicating. However, this has raised concerns about the risk that it could cause reproductive harm.
That is precisely why the FDA does not recommend the pill for women that are pregnant. The agency said that women who may become pregnant should use contraception while taking the pills and for at least four days after. The male partners of women who could become pregnant should use contraception while taking the pills and for at least three months after.
Molnupiravir is not authorized to be taken to prevent COVID infection in people who’ve been exposed to a sick person, the FDA noted. It also can’t be taken by patients who are so sick that they’ve landed in the hospital.
The FDA warned that the two antiviral pills should not be considered a substitute for vaccination.
Side effects observed in the clinical trial included diarrhea, nausea and dizziness.
To get Merck’s pills, the F.D.A. says, patients will need to test positive for the virus and get a prescription from a health care provider no more than five days after symptoms start.
For more information on COVID, visit our COVID-19 resource center.
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