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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