Btobioinnovation.com 

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com 

SPECIAL REPORT #21.25

Molnupiravir efficacy: an update

On November 9, we wrote that the United Kingdom was the first country in the world to approve molnupiravir for the treatment of mild COVID-19, based on an interim analysis which showed that the antiviral drug reduced the risk of hospitalisation and death by 50%

On November 26, Merck and Ridgeback Biotherapeutics provided update on results from the MOve-OUT study of molnupiravir. Data from all enrolled participants (n= 1433) showed  that the drug reduced the risk of hospitalisation or death from 9.7% in the placebo group (68/699) to 6.8% (48/709) in the molnupiravir group, for an absolute risk reduction of 3% and a relative risk reduction of 30%.

We wonder, if on the basis of this much poorer final outcome, other health authorities will consider the benefit-risk assessment of molnupiravir as favourable as the UK Medicines and Healthcare products Regulatory Agency (MHRA) did earlier this month. The complete set of data will be presented to the US FDA’s Antimicrobial Drugs Advisory Committee on November 30^th.

 Paris, November 28, 2021  

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