Another new Alzheimer's med steps closer to approval

10 May 2022

Alzheimer’s drug developer Eisai (TYO: 4523) has completed a rolling submission to the US Food and Drug Administration for its next-gen anti-amyloid beta candidate lecanemab.

Eisai is leading on development and regulatory interactions this time, taking over from its longtime partner, Biogen (Nasdaq: BIIB), with whom the Japanese firm has already secured an historic first approval for Alzheimer’s patients.

As before, the firms are seeking an Accelerated Approval from the US FDA, with the agency agreeing that the results of the Clarity AD trial, when completed, can serve as a confirmatory study to verify the clinical benefit of lecanemab.

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