The FDA accepted Biogen's Alzheimer's drug submission. Next up, a highly anticipated outside expert review
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If approved, Biogen's drug, aducanumab, would become the first medicine to slow the cognitive decline of Alzheimer's disease.
The Food and Drug Administration has agreed to review a marketing application submitted by Biogen for aducanumab, its treatment for Alzheimer's disease, the company announced Friday.

The aducanumab application was granted priority review, which means the FDA will render an approval decision no later than March 7, 2021.

According to Biogen, the FDA "plans to act early" if possible on the application, and that an advisory committee will be scheduled so that outside experts can review the aducanumab data. A date for that meeting has not yet been set.


The FDA's decision to review aducanumab was largely expected. Still, Biogen shares rose 12% to $310 in early Friday trading, mostly due to what appears to be signals from the FDA that the aducanumab data collected from two…
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