FDA approves Biogen Alzheimer's drug, says benefits outweigh risks

The FDA approved Biogen's (BIIB) Aduhelm to treat patients with Alzheimer's disease. "This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer's disease since 2003. 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," the FDA said in a statement. It added, "We ultimately decided to use the Accelerated Approval pathway - a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit.

In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer's disease outweighed the risks of the therapy." Shares of Biogen remain halted while Eli Lilly, who has an Alzheimer's disease drug in its pipeline, is up 4% to $210.78 following the news.

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