The U.S. Food and Drug Administration (FDA) has accepted Biogen’s Biologics License Application and granted priority review for the approval of aducanumab as a treatment for Alzheimer’s disease. If approved, aducanumab would be the first treatment with the potential to meaningfully change the course of Alzheimer’s disease.
Neurimmune discovered aducanumab together with a team of researchers at the University of Zurich. In 2007 Neurimmune and Biogen entered into a collaborative development and license agreement for aducanumab's development and commercialization.
“Today’s news is an important step in the development of the first disease-modifying treatment for Alzheimer’s disease,“ said Roger Nitsch, CEO of Neurimmune. “Aducanumab is a human monoclonal antibody that removes amyloid beta in patients’ brains, resulting in meaningful effects on brain functions in patients with Alzheimer’s disease. We are welcoming the FDA’s decision to accept the BLA filing and to grant priority review for aducanumab.”
Aducanumab is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease. Based on clinical data from patients with Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease, aducanumab has the potential to impact underlying disease pathophysiology, slow cognitive and functional decline and provide benefits on patients’ ability to perform activities of daily living, including conducting personal finances, performing household chores, such as cleaning, shopping and doing laundry, and independently traveling out of the home. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s.
(Press release / SK)
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