FDA approves Biogen's Alzheimer's drug, the first new therapy for the disease in nearly two decades

The Food and Drug Administration on Monday approved Biogen's Alzheimer's drug aducanumab, making it the first drug 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 FDA's decision was highly anticipated. The drug, which is marketed under the name Aduhelm, is also expected to generate billions of dollars in revenue for the company and offers new hope to friends and families of patients living with the disease.

"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."

"With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review," Cavazzoni added.

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