The U.S. Food and Drug Administration on Thursday authorized Merck & Co's antiviral pill for COVID-19, after giving the go-ahead to a similar treatment from Pfizer Inc a day earlier.
Merck's drug, molnupiravir, developed with Ridgeback Biotherapeutics, was shown to reduce hospitalizations and deaths by around 30% in a clinical trial of high-risk individuals early in the course of the illness, as opposed to 90% shown by Pfizer's anti viral drug.
It will carry a warning against use during pregnancy. Women of childbearing age should use birth control during treatment and for a few days after while men should use birth control for at least three months after their final dose, the FDA said.
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 U.S. government has a contract to buy as many as 5 million courses of the drug for $700 per course.
The drug is not authorized for use in patients younger than 18 because molnupiravir may affect bone and cartilage growth, the FDA said in a statement.