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.

Drug Review Profile: Leqembi Chronology
FDA reversed course on Leqembi's approvability after giving Aduhelm the nod. • Source: Pink Sheet/Shutterstock/Alamy

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