New Jersey-based Merck and its co-development partner Ridgeback Biotherapeutics announced on December 16, 2021, the New England Journal of Medicine (NEJM) had published findings from the Phase 3 MOVe-OUT trial evaluating molnupiravir, an investigational oral antiviral medicine, in non-hospitalized high-risk adults with mild to moderate COVID-19.
The new data demonstrated that early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high-risk, unvaccinated adults with COVID-19.
Molnupiravir is an orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19.
“The publication of these positive results in the NEJM demonstrates that molnupiravir, which was studied as a single medicine that can be taken at home – regardless of food intake, with no known drug-drug interactions and without required dose modifications for those with kidney or liver impairment – has the potential to be a valuable addition to the therapeutic options available to fight COVID-19,” said Wendy Holman, CEO, Ridgeback Biotherapeutics, in a press release.
As in previous trials, no safety concerns with molnupiravir were identified in the phase 3 study.
In addition, there was no evidence of a pattern of clinically meaningful abnormalities in laboratory test results. The incidence of any adverse event was comparable in the molnupiravir and placebo groups (30.4% and 33.0%, respectively).
In anticipation of regulatory authorization or approval, Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with at least 20 million courses to be made in 2022.
Furthermore, Merck entered into a procurement agreement with the U.S. Government. As a result, the company will supply approximately 3.1 million courses of molnupiravir upon authorization or approval from the U.S. Food and Drug Administration.
Molnupiravir is authorized in the U.K as the first oral antiviral for the treatment of mild to moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness.
And the European Medicines Agency recently issued a positive scientific opinion for molnupiravir.
As of December 17, 2021, regulatory applications are under review or are in the process of being submitted, including applications for Emergency Use Authorization in Japan and the U.S.
