Controversial Alzheimer’s Drug FDA Approved

Having been nearly two decades since the Food and Drug Administration approved an Alzheimer’s treatment, Biogen’s Alzheimer’s disease drug, aducanumab, has been approved. Marketed under the name “Aduhelm,” it becomes the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s. 

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. 

Alzheimer’s disease is a progressive neurodegenerative disorder that slowly destroys memory and thinking skills. More than 6 million Americans are living with it, according to the Alzheimer’s Association. By 2050, that number is projected to rise to nearly 13 million, according to the group.

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Big move for the fight against Alzheimer’s

This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid-beta plaques in the brain. The clinical trials for Aduhelm were the first to show that a reduction in these plaques (a common finding in the brain of patients with Alzheimer’s) is expected to lead to a reduction in the clinical decline of this devastating form of dementia.

“It is a new day,” Harry Johns, CEO of the Alzheimer’s Association, said in a statement. “This approval allows people living with Alzheimer’s more time to live better. For families, it means being able to hold on to their loved ones longer. It is about reinvigorating scientists and companies in the fight against this scourge of a disease. It is about hope.”

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