Biogen Inc. (BIIB) announced Wednesday that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer's disease.
The Fast Track designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious conditions and address unmet medical needs.
BIIB080 is the first tau-targeting ASO to enter clinical development for Alzheimer's disease and is currently being evaluated in the global Phase 2 CELIA study in individuals with early-stage disease.
As previously announced, results from the 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.
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