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DewDiligence

12/23/21 9:52 AM

#240976 RE: DewDiligence #240529

FDA grants EUA for MRK’s Molnupiravir—with_a_major_limitation:

https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-for-treatment-of-covid-19-in-certain-adults-301450419.html

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck's molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.

Emphasis added.

The limitation is warranted, IMO, in light of Molnupiravir’s weak efficacy and questionable safety.