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A Much Anticipated Alzheimer's Drug Approved by FDA

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On Monday, FDA approved Biogen's ( (BIIB) - Get Biogen Inc. Report) Adhuhelm using the 'Accelerated Approval" pathway, according to TheStreet's Rob Lenihan. 

The news is giving a big boost to the biotech sector.  Shares of the Cambridge, Mass., company were up slightly to $286.43 at last check. The drugmaker's shares have risen nearly 17% year to date.

"This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003," the Agency said, in a statement. "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 hallmark 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."

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