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DewDiligence

02/24/23 12:24 PM

#852 RE: DewDiligence #834

EMA rejects MRK’s MAA for Molnipiravir:

https://www.businesswire.com/news/home/20230223006077/en

Merck and Ridgeback Biotherapeutics today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the refusal of the marketing authorization for LAGEVRIO (molnupiravir) for the treatment of certain adults who have been diagnosed with COVID-19 in the European Union (EU). Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.

The appeal would seem to be fruitless. Molnupiravir is simply a bad drug that doesn’t deserve (non-emergency) marketing authorization.