The Food and Drug Administration (FDA) has granted Fast Track designation to the investigational drug aducanumab (Biogen) for the treatment of early Alzheimer’s disease (AD).

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

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Interim analysis of PRIME showed consistent data from previously reported studies, and demonstrated a reduction in amyloid plaque levels in patients treated with aducanumab. Results from PRIME supported the design of the ongoing Phase 3 ENGAGE and EMERGE studies, two global trials designed to evaluate the safety and efficacy of aducanumab in slowing cognitive impairment and the progression of disability in patients with early AD. Biogen intends to present detailed results from these trials at upcoming medical meetings.

Aducanumab (BIIB037) 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).

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