Eisai to complete FDA submission of next Alzheimer’s drug in 1Q fiscal 2022
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Eisai (OTCPK:ESALY) (OTCPK:ESALF) expects to complete the rolling submission for its lecanemabâs Biologics License Application (BLA) to the FDA under the regulatorâs accelerated approval pathway in 1Q fiscal 2022. The Japanese drugmaker is advancing the experimental Alzheimerâs drug in partnership with Biogen (NASDAQ:BIIB).

The announcement came a day after the Centers for Medicare & Medicaid Services (CMS) announced its final decision to restrict the coverage for Aduhelm, an Alzheimerâs drug cleared by the FDA last year under accelerated approval.
The company expects to share the data from Clarity AD, Phase 3 confirmatory trial in the Fall of 2022, and Eisai (ESALY) thinks that the trial has a strong design that could meet the Medicare criteria to win full coverage subject to the FDA approval of the anti-amyloid drug.
Last September, Eisai (ESALY) and Biogen (BIIB) announced the initiation of BLA submission for lecanemab under the accelerated approval pathway.