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# Biogen Completes Alzheimer’s Treatment BLA
- URL: https://www.fdaweb.com/biogen-completes-alzheimers-treatment-bla/
- Published: 2020-07-08T12:00:00.000Z
- Updated: 2026-09-14T16:20:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147148

Biogen and Eisai say that Biogen has completed the submission of a BLA to FDA for approval of aducanumab, an investigational treatment for Alzheimer’s disease. A company [statement](https://investors.biogen.com/news-releases/news-release-details/biogen-completes-submission-biologics-license-application-fda?ref=fdaweb.com) says the completed submission followed ongoing collaboration with the agency and includes data from the Phase 3 EMERGE and ENGAGE studies and the Phase 1b PRIME study.

Biogen says that if aducanumab is approved, it would be the first therapy to reduce the clinical decline of Alzheimer’s disease and also would be the first therapy to demonstrate that removing amyloid-beta resulted in better clinical outcomes.

FDA now has 60 days to decide whether to accept the BLA for review. The company says it expects to hear at the same time whether the BLA has been accepted for priority review.