In an effort to bring molnupiravir to COVID-19 patients around the world as fast as possible, an Emergency Use Authorization (EUA) application for molnupiravir has been submitted to the United States Food and Drug Administration (US-FDA) for the management of mild-to-moderate COVID-19 in adults who are in danger of advancing to severe coronavirus infection and/or hospitalization, as per the notification published on 11 October 2021.

Molnupiravir, an investigational orally administered antiviral medicine, showed favorable outcomes in the planned interim analysis from the Phase 3 MOVe-OUT clinical trial. This trial investigated the efficacy of molnupiravir in non-hospitalized adults suffering from mild-to-moderate coronavirus infection and who were susceptible to progress to severe SARS-CoV-2 infection and/or hospital admission.

The antiviral agent was found to minimize the risk of hospitalization or mortality by about 50%. Overall, 7.3% of participants who were given molnupiravir were either hospitalized or died through day twenty-nine following randomization vs. 14.1% of placebo recipients. Through day twenty-nine, there were no deaths noted in molnupiravir recipients vs. placebo recipients.

Both the groups showed a comparable occurrence of any adverse event and drug-related adverse events. Compared to the placebo group, fewer participants in the molnupiravir group discontinued therapy due to adverse events, as shown in Table 1:

The submission of EUA application to FDA is a crucial step towards making molnupiravir available to individuals who may benefit from an orally administered antiviral drug that can be taken at home shortly following diagnosis with SARS-CoV-2 infection. Molnupiravir is also being investigated for post-exposure prophylaxis in MOVe-AHEAD, a randomized phase III study that is exploring molnupiravir's efficacy and safety to prevent coronavirus spread within the households.