A new Alzheimer’s drug: From advisory panel to FDA — what’s at stake here? – Harvard Health Blog

It’s been more than 17 years since the FDA last approved an Alzheimer’s drug. Will Biogen’s drug, called aducanumab, end this drought? The FDA will decide by March 2021, based on its own analysis of clinical trial data and an advisory panel’s review of the evidence.

How does the drug work?

Aducanumab is a monoclonal antibody engineered in a laboratory to stick to the amyloid molecule that forms plaques in the brains of people with Alzheimer’s. Most researchers believe that the plaques form first and damage brain cells, causing tau tangles to form inside them, killing the cells. Once aducanumab has stuck to the plaque, your body’s immune system will come in and remove the plaque, thinking it’s a foreign invader. The hope and expectation is that, once the plaques are removed, the brain cells will stop dying, and thinking, memory, function, and behavior will stop deteriorating.

Will the FDA’s decision be important?

If aducanumab works, it would be the first drug that actually slows down the progression of Alzheimer’s. That means we could possibly turn Alzheimer’s from a fatal disease into one that people could live with for many years, in the same way that people are living with cancer, diabetes, and HIV/AIDS.

For researchers, it means that more than 20 years of scientific work, which suggests that removing amyloid from the brain can cure Alzheimer’s, may be correct. But many of us have begun to doubt this theory, because trial after trial has shown that amyloid could be cleared from the brain but clinical disease progression was not altered.

So, does the drug work?

I attended the day-long FDA hearing on November 6, 2020, and also independently reviewed all the publicly available data for aducanumab. There was one small (phase 2) clinical trial to assess efficacy and side

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