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Eisai Bets On Accelerated Approval For Biogen-Partnered Lecanemab

Filing Before Pivotal Data Beats Lilly’s Pre-Phase III Submission

 
• By Mandy Jackson

Following Biogen’s lead with Aduhelm, the first disease-modifying Alzheimer’s therapy approved in the US, Eisai began a rolling BLA submission for lecanemab (BAN2401) ahead of next year’s Phase III results. 

Pair of aces with poker chips
Time will tell if Eisai and Biogen are holding a pair of aces with Aduhelm and lecanemab • Source: Alamy

Eisai Co., Ltd. confirmed late on 27 September that it has initiated a rolling biologics license application (BLA) submission for its anti-amyloid-beta protofibril antibody lecanemab (BAN2401) ahead of Phase III data expected in 2022, finally resolving a question opened by the US Food and Drug Administration accelerated approval of it and Biogen, Inc.’s amyloid-clearing antibody Aduhelm (aducanumab) for Alzheimer’s disease.

Aduhelm was approved in June under the subpart H pathway based on its ability to clear amyloid plaques from the brains of Alzheimer’s patients, with the requirement of a confirmatory trial to show amyloid reduction leads to slower cognitive decline. (Also see "Biogen/Eisai Win On Aduhelm Approval Bet And Wager Next On Price" - Scrip, 7 June, 2021

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