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# Eisai/Biogen Claim Lecanemab Trial Success
- URL: https://www.fdaweb.com/eisai-biogen-claim-lecanemab-trial-success/
- Published: 2022-09-28T12:00:00.000Z
- Updated: 2026-09-14T18:01:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152837

Eisai and Biogen say the Phase 3 confirmatory Clarity AD trial of their lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody to treat mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease with confirmed presence of amyloid pathology, successfully met all primary and secondary endpoints. A [statement](https://eisai.mediaroom.com/2022-09-27-LECANEMAB-CONFIRMATORY-PHASE-3-CLARITY-AD-STUDY-MET-PRIMARY-ENDPOINT,-SHOWING-HIGHLY-STATISTICALLY-SIGNIFICANT-REDUCTION-OF-CLINICAL-DECLINE-IN-LARGE-GLOBAL-CLINICAL-STUDY-OF-1,795-PARTICIPANTS-WITH-EARLY-ALZHEIMERS-DISEASE?ref=fdaweb.com) says the companies plan to file for traditional FDA approval by 3/31/23\. They have already submitted a BLA for accelerated approval of lecanemab, which FDA accepted in July. The PDUFA action date on the BLA is 1/6/23.

The statement says the primary and secondary endpoints were met with “highly statistically significant results.”

Eisai and Biogen say FDA has agreed that the results of Clarity AD can serve as the confirmatory study to verify lecanemab’s clinical benefit.