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Relitigating Aduhelm: CDER’s Cavazzoni Uses Leqembi Approval To Defend Aducanumab Decision

 
• By Sue Sutter

Although Aduhelm’s accelerated approval in June 2021 ‘generated a significant amount of discussion among external stakeholders,’ CDER’s work on that application ‘led to a leap in our understanding of amyloid as a surrogate marker and a greater understanding of the role that a reduction in amyloid plaque may play in a slowing of the disease,’ drug center director says.

Shield and sword
CDER defended Aduhelm's approval in its announcement of Leqembi's licensure. • Source: Shutterstock

The US FDA’s Center for Drug Evaluation and Research leadership used the occasion of its second accelerated approval of a potentially disease-modifying Alzheimer’s treatment to defend its still-controversial approval of the first one.

The agency licensed Eisai Co., Ltd. and Biogen, Inc.’s Leqembi (lecanemab-irmb) on 6 January, making it the second...

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