Biogen's (BIIB) Aducanumab Receives FDA Fast-Track Designation as Alzheimer’s Disease Treatment

September 1, 2016 4:05 PM EDT

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Biogen (Nasdaq: BIIB) announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The FDA’s Fast Track program supports the development of new treatments for serious conditions with an unmet medical need such as Alzheimer’s disease.

“By collaborating with regulators through programs like Fast Track, we hope to bring effective treatments to patients and families affected by Alzheimer’s disease as quickly as possible,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen.

Aducanumab is currently being evaluated in two global Phase 3 studies, ENGAGE and EMERGE, which are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability in people with early Alzheimer’s disease.

For more information about the Phase 3 studies, including information about participating centers, visit www.ClinicalTrials.gov (NCT02477800 or NCT02484547).

Update: Phase 1b Data

PRIME is the ongoing Phase 1b randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical effects of aducanumab in patients with prodromal or mild AD.

The placebo-controlled portion of the study included fixed doses of aducanumab at 1, 3, 6 and 10 mg/kg and a titration regimen. PRIME also has a long-term extension for patients who completed the one-year placebo-controlled portion of the study.

In a recently completed interim analysis from PRIME, efficacy and safety data were consistent with results previously reported. These data support the design of the ongoing Phase 3 ENGAGE and EMERGE studies. Biogen plans to share detailed information about these results at upcoming medical meetings.

About AducanumabAducanumab (BIIB037) is an investigational compound being developed for the treatment of early AD. Aducanumab is a human recombinant monoclonal antibody (mAb) 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 (RTM). Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Aducanumab is thought to target aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of AD patients. Based on pre-clinical and interim Phase 1b data, treatment with aducanumab has been shown to reduce amyloid plaque levels.



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