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# Biogen Gets Fast Track for Alzheimer’s Therapy
- URL: https://www.fdaweb.com/biogen-gets-fast-track-for-alzheimers-therapy/
- Published: 2025-04-02T12:00:00.000Z
- Updated: 2026-09-14T14:56:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158937

FDA has granted Biogen a fast-track designation for BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau in treating Alzheimer’s disease. The company says BIIB080 is the first tau-targeting ASO to enter clinical development for Alzheimer’s, and it is currently being evaluated in the Phase 2 CELIA study in individuals with early-stage disease.

[Previously announced](https://www.globenewswire.com/Tracker?data=PNlf6IMsSOKHRZslSSJCsgDsD3kXzCj1oJ016IbGQYFLdGKYWLLX6da3AtMTVpIdMTIUwuwTH1tad84aTcueVu04nSKqPexrOmapLv91HQJl57MyDEApG0%5F2G0scmVjk91%5Fk2Rrrf93OYLQIUTubfRJB0S%5Fpwik0hyBvi%5FaypD6t2VL-2RTWABElACHHeZ0rQ86w3t7N%5FpmWWab2cWTztbXucP2KoHlANFhnaHqf7d4=&ref=fdaweb.com) results from a Phase 1b study “showed dose-dependent reductions in soluble tau protein in cerebrospinal fluid (CSF), decreases in aggregated tau pathology in the brain as measured by positron emission tomography (PET), and favorable trends in exploratory clinical outcomes, supporting the potential for clinical benefit,” Biogen says. In those taking high doses of the therapy, “favorable trends” were observed across multiple exploratory measures of cognition and function, it adds.

The therapy is designed to target microtubule-associated protein tau mRNA to reduce tau protein production, Biogen says. “Abnormal accumulation of tau in the brain is a hallmark of Alzheimer’s disease and is associated with neurodegeneration and cognitive decline,” it says.