Biogen’s Alzheimer’s drug gets FDA fast-track status

The fast track status provides for more frequent meetings with the FDA review team and a rolling review of the new drug application.

Biogen executive vice president and chief medical officer Alfred Sandrock said: “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.”

Biogen licensed aducanumab from Neurimmune under a collaborative development and license deal.

Aducanumab is a human recombinant monoclonal antibody derived from a library of B cells collected from healthy elderly subjects with no indications of cognitive impairment.

It is believed to target aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of AD patients.

In a phase 1b study, patients receiving aducanumab demonstrated a statistically significant reduction in beta amyloid in the brain.

Aducanumab is currently being assessed in two global Phase 3 studies, which are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability in people with early AD.

AD is a chronic neurodegenerative disease that usually starts slowly and gets worse over time. It is the cause of 60% to 70% of cases of dementia.

It was estimated in 2010 that 25 million individuals were living with AD globally.

Image: Biogen’s investigational Alzheimer’s disease treatment aducanumab granted FDA fast track designation. Photo: courtesy of Biogen.