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Aduhelm Shows Need For More FDA Transparency On Approval Decisions, Surrogate Endpoints, Critics Say

 
• By Sue Sutter

But Center for Drug Evaluation and Research leaders stand their ground at a National Academies meeting, asserting the Phase III data for a different Alzheimer’s drug, Leqembi, are likely to confirm their views on utility of amyloid as a surrogate endpoint.

Thorns
Twenty months later, the Aduhelm accelerated approval remains a thorn in CDER's side. • Source: Shutterstock

A recent National Academies meeting on accelerated approval provided yet another forum for harsh criticism of the US Food and Drug Administration’s approval of Biogen, Inc.’s Alzheimer’s drug Aduhelm (aducanumab-avwa), leading to calls for increased transparency into FDA decision-making and its thinking on surrogate endpoints.

Yet, it also provided an opportunity for Center for Drug Evaluation and Research officials to once again defend the Aduhelm...

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