Alzheimer's Disease Treatment Receives FDA Fast Track Designation
Aducanumab shows ability to reduce amyloid plaque levels in an interim analysis of a phase 1b study.
The FDA has granted Biogen’s experimental drug aducanumab Fast Track Designation for the treatment of Alzheimer’s disease.
The Fast Track designation indicates that a drug can potentially treat a serious condition that has unmet needs, such as Alzheimer’s disease, according to Biogen. Aducanumab is a human recombinant monoclonal antibody thought to target aggregated forms of beta amyloid in the brains of patients with Alzheimer’s disease.
Based on data collected in pre-clinical and clinical studies, the drug has been found to reduce amyloid plaque levels, Biogen reported. Amyloid plaques have been known to cause neurofibrillary degeneration and irreversible memory loss associated with the disease.
PRIME is an ongoing phase 1b study analyzing the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical effects of the drug in patients with prodromal or mild Alzheimer’s disease, according to Biogen.
An interim analysis of the study indicated the same efficacy and safety, as previously reported, and supports the design of the phase 3 studies. ENGAGE and EMERGE are phase 3 studies analyzing the safety and efficacy of aducanumab in slowing cognitive impairment and progression in patients with early 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, MD, PhD, executive vice president and chief medical officer at Biogen.