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

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

Tuba Khan

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

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  • 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

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