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# FDA Priority Review for Biogen/Eisai BLA for Alzheimer’s
- URL: https://www.fdaweb.com/fda-priority-review-for-biogen-eisai-bla-for-alzheimers/
- Published: 2020-08-07T12:00:00.000Z
- Updated: 2026-09-14T16:24:19.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147383

FDA has accepted for priority review a Biogen and Eisai BLA for aducanumab, an investigational treatment for Alzheimer’s disease. The agency has set a user fee review action date of 3/7/2021\. If approved, aducanumab would be the first therapy for reducing Alzheimer’s “clinical decline,” according to the companies. It would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes. Aducanumab is a monoclonal antibody licensed from Neurimmune under a collaborative development agreement.

The submission is based on data from the EMERGE and ENGAGE Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies. The primary objective was reducing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes score, Biogen and Eisai say. Secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical decline as measured by the Mini-Mental State Examination, Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 Items and Alzheimer’s Disease Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version.