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

The accelerated approval Biogen, Inc. and Eisai Co., Ltd.’s amyloid-targeting antibody Aduhelm (aducanumab-avwa) for Alzheimer’s disease was a seminal moment in the development of the companies’ Leqembi (lecanemab-irmb) for the same population.

In comments prior to and during an October 2018 meeting, the US Food and Drug Administration’s Division of Neurology Products told the companies in no uncertain terms that the results from Study 201 did not provide substantial evidence to support either regular approval

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