FDA Fast Tracks Biogen’s Alzheimer’s DrugBy
Biogen was granted fast track designation by the US Food and Drug Administration for aducanumab, its investigational treatment for early Alzheimer's disease (AD).
Aducanumab is currently being evaluated in two global Phase III studies that are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability in people with early AD.
Aducanumab is a human recombinant monoclonal antibody that Biogen licenced from Zurich, Switzerland-based Neurimmune, a biopharmaceutical company, under a collaborative development and license agreement. It is derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune's technology platform called Reverse Translational Medicine .