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
Click here to read full press release/ article | Ref: Merck | Image: The Conversation
The post Merck and Ridgeback Report the Initiation of EMA Rolling Review of Molnupiravir for the Treatment of COVID-19 first appeared on PharmaShots.
