Btobioinnovation.com 

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

SPECIAL REPORT #21.28

US FDA approves Paxlovid

On December 22, the U.S. FDA has given Pfizer’s Paxlovid an Emergency Use Approval (EUA) for the treatment of mild COVID-19, based on a study which showed the drug reduced the risk of hospitalisation and death by 89%.

To many observers this new anti-viral agent could become a real game changer if its activity is confirmed against new variants of COVID-19. “Today’s authorisation of Paxlovid represents another tremendous example of how science will help us ultimately defeat this pandemic which, even two years in, continues to disrupt and devastate lives across the world” Pfizer CEO Albert Bourla said in a statement.

The recommended course of treatment consists of 20 Paxlovid pills – a selective protease inhibitor which inhibits the replication of the virus – and 10 Ritonavir pills – another protease inhibitor already used in the treatment of HIV- whose action prolongs the activity of Paxlovid.  The U.S. approved treatment has shown clear superiority over Merck and Ridgeback’s molnupiravir, already approved in the U.K. since early November, but not in the U.S., where more data on safety are required.

Pfizer has agreed to rapidly supply the United States with 10 million courses of Paxlovid for $5.29 billion ($529 per course). According to a recent SVB Leering analysis, the drug could generate as much as $24.2 billion in Pfizer’s 2022 sales.

Paris December 23, 2021

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