Biogen drug becomes first FDA-approved Alzheimer's treatment in 2 decades

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The FDA on June 7 approved Biogen's Alzheimer's drug aducanumab, the first approval the agency has granted to an Alzheimer's treatment since 2003.

Aducanumab, branded under the name Aduhelm, is the first treatment approved by the FDA to slow cognitive decline from Alzheimer's, as the Alzheimer's drugs the FDA has previously cleared are aimed at alleviating symptoms rather than slowing the disease's progression.

The drug's approval has been a prevalent topic among the medical community, media and families of Alzheimer's patients. Patrizia Cavazzoni, MD, the director of the FDA's Center for Drug Evaluation and Research, said the agency is "well-aware of the attention surrounding this approval."

"At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward," Dr. Cavazzoni said. "We examined the clinical trial findings with a fine-tooth comb, we solicited input from the Peripheral and Central Nervous System Drugs Advisory Committee, we listened to the perspectives of the patient community, and we reviewed all relevant data."

The FDA cleared aducanumab using its accelerated approval pathway, which is used when a treatment's approval would provide earlier access to treatments for patients with serious diseases where there is an unmet need.

The agency said it will continue to monitor aducanumab as patients begin to take it, as well as require Biogen to conduct a post-approval clinical trial to verify the drug's clinical benefits.

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