The FDA has granted accelerated approval for Aduhelm (aducanumab), a drug used to treat Alzheimer’s disease. Drugs approved under the accelerated approval pathway have proven to be more beneficial than what’s currently on the market for life-threatening illnesses. Considering Aduhelm is the first drug of its kind and the first Alzheimer’s treatment to be approved since 2003, this breakthrough drug brings hope to the 6.2 million Americans living with the disease and the loved ones affected.
A statement provided by the FDA:
“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,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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 is made by Biogen of Cambridge, Massachusetts. The drug’s effectiveness was tested in three individual studies, representing 3,482 patients. These studies included randomized, double-blind, and placebo-controlled dose-ranging studies in patients with Alzheimer’s disease. An indicating sign of Alzheimer’s disease is a buildup of amyloid beta plaque in the brain. In the studies conducted, patients receiving Aduhelm showed a significant reduction of amyloid beta plaque, while the placebo patients showed no reduction of amyloid beta plaque. These impressive results supported the acceleration of FDA approval.
For more information on Alzheimer’s disease, click here for the official CDC webpage.