Merck and Ridgeback Report EUA Submission to the US FDA for Molnupiravir to Treat COVID-19
Shots:
- The P-III MOVe-OUT trial evaluates molnupiravir vs PBO in non-hospitalized adult patients with COVID-19 with 1 risk factor associated with poor disease outcomes & symptom onset within 5 days before randomization
- The interim analysis showed ~50% reduction in risk of hospitalization or death; patients who received therapy were either hospitalized or died @29 Days (7.3% vs 14.1%) following randomization- no deaths were reported- treatment discontinuation due to AEs (1.3% & 3.4%) respectively
- The companies continue to work with regulatory agencies globally to submit applications for EUA or MAA in the coming mos. If authorized- the therapy will be the 1st oral antiviral medicine for COVID-19
Ref: Merck | Image: Merck
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