It becomes the first drug cleared by US regulators to slow cognitive decline in people living with Alzheimer’s in nearly two decades.
The Food and Drug Administration (FDA) approved Biogen’s Alzheimer’s disease drug aducanumab on Monday, making it the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.
The drug, which is marketed under the name Aduhelm, is also expected to generate billions of dollars in revenue for the company andoffers new hope to friends and families of patients living with the disease. Biogen’s stock was halted for the announcement.
“We are well-aware of the attention surrounding this approval,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders.”