The Food and Drug Administration approved Merck’s antiviral pill, molnupiravir, for emergency use to treat Covid-19, it said Thursday, a day after it greenlit Pfizer’s antiviral drug, adding new tools to combat the virus as new infections increase in the country.
Merck’s drug is used to treat mild-to-moderate cases of Covid in adults who are at high risk of developing severe disease or when “alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate,” the agency said in a statement Thursday.
Merck’s pill, developed with Ridgeback Biotherapeutics, reduced the risk of hospitalization and death by 30%, the drugmaker said last month.
Molnupiravir is not authorized for use for patients under 18 years old because it “may affect bone and cartilage growth,” according to the FDA.
The pill is not recommended for use during pregnancy.
Molnupiravir is only available by prescription, and patients should take four 200 milligram pills every 12 hours within five days of symptom onset for no longer than five days in a row.
The U.S. government has ordered around 3 million courses of Merck’s pill.
An FDA expert panel narrowly endorsed Merck’s drug in a 13-10 vote last month. However, several health advisers on the committee voiced concerns about the pill’s possibility to produce mutations to the virus, the Washington Post reported. “Even if the probability is very low, 1 in 10,000 or 100,000, that this drug would induce an escape mutant from which the vaccines we have do not cover,” Dr. James Hildreth, CEO of Meharry Medical College in Tennessee, told the FDA panel. He went on to say, “That could be catastrophic for the whole world actually,” CNBC reported.
Wednesday, the FDA greenlit Pfizer’s antiviral drug, Paxlovid, for patients 12 years and older with mild-to-moderate cases of Covid who are at high risk of hospitalization or death. Paxlovid prevented hospitalization due to Covid by 89%, the drugmaker said.