Biogen announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was granted Fast Track designation by the US Food and Drug Administration (FDA). The FDA’s Fast Track programme 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.

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.

Aducanumab (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.

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder characterized by cognitive decline and behavioral disturbances that eventually result in a person’s inability to perform daily activities. In 2010, it was estimated that 25 million individuals were living with AD worldwide. Evidence suggests that pathophysiological changes typically begin years prior to the symptoms that lead to a clinical diagnosis. As the disease progresses, cognitive impairments, behavioral changes and functional disability commonly associated with AD begin to manifest.