Leqembi Clinical Development: Aduhelm Opened The Door For Accelerated Approval
Timeline of lecanemab’s clinical development shows how, almost three years after telling Eisai and Biogen that their Phase II results did not support regular or accelerated approval, the FDA review division reversed course following its decision to approve aducanumab on a surrogate endpoint.
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Leqembi Safety: Label Has Distinct MRI Schedule But Follows Aduhelm On ARIA Management
With the second amyloid-targeting antibody for treatment of Alzheimer’s, US FDA opted for a class-wide approach to management of amyloid-related imaging abnormalities, but with a product-specific MRI monitoring schedule that differs from that of Aduhelm.
Leqembi Phase II Missed Clinical Endpoint But Still Provided Support For Amyloid Surrogate
Pink Sheet's Drug Review Profile digs into the FDA memos on Eisai/Biogen’s lecanemab; Phase II clinical efficacy results were reviewed for whether they supported the likelihood of amyloid plaque reduction to predict clinical benefit, rather than whether they directly provided substantial evidence of effectiveness.
Biogen’s Aducanumab: Why Accelerated Approval Might, And Might Not, Be An Option For US FDA
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.