Merck and Ridgeback’s Molnupiravir Receive MHLW’s Approval for the Treatment of COVID-19
Shots:
- The approval is based on the P-III (MOVe-OUT) trial to evaluate molnupiravir (800mg, bid) vs PBO in non-hospitalized unvaccinated adult patients with COVID-19 with 1 risk factor associated with poor disease outcomes
- In an interim & randomized analysis, 50% & 30% relative reduction in risk of hospitalization or death @29 Day, (7.3% vs 14.1%) were hospitalized or died, 6.8% & 3.0% absolute risk reduction, (6.8% vs 9.7%) had a lower risk of hospitalization or death @ 29 Day in the randomized analysis
- Molnupiravir is the 1st oral COVID-19 antiviral medicine to receive authorization globally while the regulatory submission is currently under review & are marketed as Lagevrio outside the US
Ref: Merck | Image: Merck
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