FDA Approves First Alzheimer’s Treatment in 18 Years. Now What?

For the first time since 2003, a new medication to help slow the cognitive decline caused by Alzheimer’s disease was approved on Monday by the US Food and Drug Administration.

The drug from the biotech giant Biogen is called aducanumab (the brand name will be Aduhelm) and is aimed at people who have shown signs of early-stage dementia caused by Alzheimer’s. What makes it especially momentous is that unlike previous approved treatments that helped ease the symptoms of Alzheimer’s, the new medication is designed to actually slow the disease’s impact on brain function.

The news was not without controversy. In an unusual step, Biogen has been told by the FDA it must still conduct studies, post-approval, confirming that aducanumab works. The decision was made under the agency’s accelerated approval process, which allows for earlier approval of drugs treating serious or life-threatening conditions.

In a lengthy statement from the FDA, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said that clinical trials showed that the reduction in plaque “is expected to lead to a reduction in the clinical decline of this devastating form of dementia.”

But she also acknowledged there has been widespread debate about the drug and how effective it will be. Ultimately, she said, the FDA “concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”

With the significant news Monday, The Brink spoke with Benjamin Wolozin, Boston University School of Medicine professor of pharmacology and experimental therapeutics, whose research includes examining neurodegenerative diseases, such as Alzheimer’s, ALS, and Parkinson’s.

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