FDA fast-tracks Biogen's investigational Alzheimer's drug aducanumab

The US Food and Drug Administration has granted Fast Track designation for biotech major Biogen’s (Nasdaq: BIIB) aducanumab, its investigational treatment for early Alzheimer’s disease (AD). 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, executive vice president and chief medical officer at Biogen.

Aducanumab is currently being evaluated in two global Phase III 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.