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Biogen’s Aducanumab: Why Accelerated Approval Might, And Might Not, Be An Option For US FDA

Executive Summary

Use of expedited pathway based on drug’s effect on brain amyloid would be problematic given advisory committee’s views of a disconnect between biomarker data and clinical efficacy results; however, one FDA expert sees potential for agency to grant accelerated approval on basis of an intermediate clinical endpoint – the same endpoint on which Biogen seeks regular approval.

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