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The Conflicting Lessons Of Aduhelm

 
• By Michael McCaughan

US FDA is understandably feeling vindicated about the decision to use beta amyloid as a surrogate marker in Alzheimer’s. But the agency needs to be careful because critics of its landmark accelerated approval decision for Aduhelm are not arguing about the science.

US FDA's approval of Aduhelm has produced no shortage of drama. • Source: Shutterstock

When it comes to the role of beta amyloid as a surrogate marker for disease progression in Alzheimer’s, it is very understandable if US Food & Drug Administration officials are tempted to say, “I told you so.”

The agency’s 2021 decision to grant accelerated approval to Biogen, Inc.’s Aduhelm (aducanumab-avwa) based on that biomarker prompted a...

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