FDA green lights second oral antiviral for COVID-19, but only in certain adults

Following an Antimicrobial Drugs Advisory Committee narrow vote of 13-10 last month in favor of the anitviral’s benefits, the US Food and Drug Administration today issued an emergency use authorization (EUA) for Merck & Co’s (NYSE: MRK) molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19).

The EUA is for use in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.

Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth. It is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19 because benefit of treatment has not been observed in people when treatment started after hospitalization due to COVID-19.