Merck and Ridgeback Report EUA Submission to the US FDA for Molnupiravir to Treat COVID-19

October 11, 2021 Auto Bot EUA, FDA, Merck, molnupiravir, regulatory, Ridgeback 0

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

Click here to­ read full press release/ article | Ref: Merck | Image: Spagnola & Associates

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