Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the United Kingdom (U.K.) for molnupiravir (MK-4482, EIDD-2801).
The companies said it is the first oral antiviral medicine authorized 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.
In the U.K., LAGEVRIO is the planned trademark for molnupiravir. Merck and Ridgeback, a biotechnology company focused on emerging diseases, also said the U.S. Food and Drug Administration (FDA) is reviewing an application for emergency use authorization (EUA) of molnupiravir. In addition, they said the European Medicines Agency has initiated a rolling review of a Marketing Authorization Application. Merck said it is actively working to submit applications to other regulatory agencies around the world.
The authorization is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir 800 mg taken twice-daily by non-hospitalized, unvaccinated adult patients with laboratory-confirmed mild-to-moderate COVID-19, symptom onset within five days of study randomization, and at least one risk factor associated with poor disease outcomes (e.g., heart disease, diabetes).
In anticipation of the results from MOVe-OUT and the potential for 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 produced in 2022.
Earlier this year, Merck entered into a procurement agreement with the U.S. government under which the company will supply approximately 1.7 million courses of molnupiravir to the U.S. government, upon EUA or approval from the FDA. Merck also has a contract with the U.K. government for 480,000 courses of therapy and is currently in discussions with additional governments.
Molnupiravir (MK-4482, EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the virus that causes COVID-19.
Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University; Emory/DRIVE received some research funding from the U.S. Department of Defense and the National Institutes of Health. Molnupiravir is being developed by Merck & Co. in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from Merck and is eligible to receive contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones. Any profits from the collaboration will be split between the partners equally. Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by Merck and by Wayne and Wendy Holman of Ridgeback.
Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households.