Merck and Ridgeback Biotherapeutics have submitted an Emergency Use Authorisation (EUA) application to the US FDA for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalisation.
The companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorisation in the coming months.
The submission is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir in non-hospitalised adult patients with mild-to-moderate COVID-19 who were at risk for progressing to severe COVID-19 and/or hospitalisation.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Robert M. Davis, CEO and president of Merck.
