Merck and Ridgeback Report the Initiation of EMA Rolling Review of Molnupiravir for the Treatment of COVID-19

Shots:

• The submission is based on the P-III MOVe-OUT trial that evaluates molnupiravir (800mg, bid) in non-hospitalized adult patients with COVID-19
• At the interim analysis, the therapy showed a ~50% reduction in risk of hospitalization or death; patients were hospitalized (7.3% vs 14.1%) through 29Day following randomization, no deaths were reported in patients who received molnupiravir
• If EC grants Marketing Authorization, Molnupiravir will be the 1st antiviral therapy to treat COVID-19 in the EU. On Oct 11, 2021, Merck had submitted an application for EUA to the US FDA for molnupiravir while additional submissions to regulatory agencies globally are ongoing

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