After nearly 20 years, a new treatment for Alzheimer's has been approved by the U.S. Food and Drug Administration (FDA); Aduhelm from Biogen was approved by the FDA on Monday.
While it is the first new treatment for the disease since 2003, Aduhelm is also the first medicine for Alzheimer’s in terms of addressing an essential pathology of the disease by decreasing amyloid beta plaques in the brain. Aducanumab, according to Neurimmune, is a human monoclonal antibody against beta amyloid.
“Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease, as well as their loved ones,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, told the FDA website. “Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”
Aduhelm's efficacy was evaluated in two Phase 3 clinical trials. Its safety profile is well-documented in 3,482 patients, according to Biogen.
Biogen, located in Cambridge, Massachusetts, licensed Aduhelm from the biopharmaceutical Swiss company Neurimmune in 2007 under a collaborative development and license agreement.
Alzheimer's disease is currently affecting 6.2 million Americans, according to the FDA.
