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For the treatment of COVID-19 patients, an Emergency
Use Authorization application of molnupiravir has been submitted to US-FDA.
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.
Merck
Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
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