Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics have announced that Merck has submitted an Emergency Use Authorization (EUA) application to the US Food and Drug Administration (FDA) for molnupiravir.
Molnupiravir is 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 submission is based on positive results from a planned interim analysis from the phase 3 MOVe-OUT clinical trial.
At the interim analysis, molnupiravir reduced the risk of hospitalisation or death by approximately 50%.
No deaths were reported by Day 29 in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo.
The trial evaluated molnupiravir in adult patients with mild-to-moderate COVID-19 who were not hospitalised but who were at risk of progressing to severe COVID-19 and/or hospitalisation.
Out of 385 patients who received molnupiravir, 28 were hospitalised by Day 29 (7.3%). By comparison, out of 377 patients who received placebo, 53 were either hospitalised or died by Day 29 (14/1%).
“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 Davis, chief executive officer and president, Merck.
“We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible,” he added.
Wendy Holman, chief executive officer of Ridgeback Biotherapeutics said: “The submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral medicine that can be taken at home shortly after diagnosis with COVID-19.”
The companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorisation in the coming months.