Merck & Co., Inc. and Ridgeback Biotherapeutics announced that the European Medicines Agency (EMA) has initiated a rolling review for molnupiravir, an investigational oral antiviral medicine, for the treatment of COVID-19 in adults. Merck plans to work with the EMA?s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application. As previously announced, Merck has submitted an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA), and is actively working to submit applications to other regulatory agencies worldwide. 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-hospitalized adult patients with mild-to-moderate COVID-19 who were at increased risk for progressing to severe COVID-19 and/or hospitalization. At the interim analysis, molnupiravir 800 mg twice-daily reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were hospitalized through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377) that were either hospitalized or died; p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). The incidence of drug-related adverse events was also comparable (12% and 11%, respectively), and fewer patients in the molnupiravir group discontinued therapy due to an adverse event compared to the placebo group (1.3% and 3.4%, respectively). 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 even more courses expected to be produced in 2022. Merck is committed to providing timely access to molnupiravir globally, if it is authorized or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria that reflect countries? relative ability to finance their health response to the pandemic.