USFDA okays Merck's Covid Drug for use in high-risk cases

The US FDA on Thursday issued an emergency use authorisation (EUA) for MSD's antiviral medication molnupiravir for the treatment of mild-to-moderate Covid-19 in adults who are at high risk for progression to severe disease.

The USFDA also said molnupiravir should be given to those for whom alternative Covid-19 treatment options authorised by it are not accessible or where giving the drug is clinically appropriate.

The regulatory agency said molnupiravir should be initiated as soon as possible after diagnosis of Covid-19 and within five days of the onset of symptoms.


The drug is not authorised for use in patients younger than 18 years because molnupiravir may affect bone and cartilage growth. It is not authorised for the pre-exposure or post-exposure prevention of Covid-19 or for initiation of treatment in patients hospitalised due to Covid because benefit of treatment has not been observed in people when treatment started after hospitalisation.

"Authorisation gives an additional treatment option against the virus in form of a pill that can be taken orally," said Patrizia Cavazzoni, director of USFDA's Center for Drug Evaluation and Research.