Biogen's BIIB080 Gets FDA Fast-Track Designation in Alzheimer's Disease

Dow Jones

04-02

By Colin Kellaher

Biogen has won a U.S. Food and Drug Administration fast-track designation for its investigational BIIB080 therapy for the treatment of Alzheimer's disease.

Biogen on Wednesday said BIIB080 is the first tau-targeting antisense oligonucleotide therapy to enter clinical development for Alzheimer's disease and that it is currently being evaluated in a global phase 2 study in individuals in the early stages of the memory-robbing disease.

Abnormal accumulation of tau in the brain is a hallmark of Alzheimer's and is associated with neurodegeneration and cognitive decline.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Biogen in 2019 exercised a license option with Ionis Pharmaceuticals and obtained an exclusive royalty-bearing license to develop and commercialize BIIB080.

Cambridge, Mass., biotechnology company Biogen and Japan's Eisai are partners on Leqembi, which the FDA approved in 2023 for the treatment of Alzheimer's disease.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

April 02, 2025 08:08 ET (12:08 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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