FDA authorities set the stage for Merck’s molnupiravir approval in the U.S.
A panel of U.S. health advisers has set the stage for possible approval for the use of Merck’s molnupiravir to treat COVID-19.
According to an FDA report, a panel voted 13-10 with respect to the antiviral drug’s benefits outweighing its risks. The panel also took into consideration the potential for birth defects if consumed during pregnancy.
The move occurred amid the antiviral drug’s authorization in the UK, in which it became a first-of-its-kind pharmaceutical intervention thus far for combating COVID-19.
Merck’s findings of molnupiravir indicated that it may reduce the mortality risk by 30 percent among adults infected by the virus, becoming a promising intervention in the fight against mild-to-moderate cases of COVID-19.
“Merck’s drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus’ genetic code to stop it from reproducing,” a news release reads. “That genetic effect has raised concerns that the drug could spur more virulent strains of the virus.”
The FDA is expected to make a decision on the distributional authorization of molnupiravir by the end of 2021.