Biogen announced that it will pursue the U.S. Food and Drug Administration (FDA)’s regulatory approval process for its drug aducanumab to treat Alzheimer’s disease.
The decision was based on findings from the phase 4 EMERGE study, which met its primary endpoint in revealing a “significant reduction in clinical decline.” If aducanumab is approved, it will become the first treatment to demonstrate that removing amyloid beta may lead to better clinical outcomes.
Beta-amyloid is connected to Alzheimer’s based on its makeup and the fact that it can accumulate and create amyloid plaques, one of the hallmark features of a brain in patients with Alzheimer’s disease.
The Alzheimer’s Association has previously released an FAQ on beta-amyloid, which can be found here, and may be a useful resource for patients and healthcare providers.
The potential approval for aducanumab may be a pivotal option for patients with Alzheimer’s disease, and a development American Nurse Today plans to track.
Please read the entire press release here.