Neurology / Alzheimer's Disease

Controversial Alzheimer's Drug Wins FDA Approval

www.medpagetoday.com
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Aducanumab is first treatment directed at Alzheimer's pathophysiology
The controversial Alzheimer's treatment aducanumab (Aduhelm) won FDA approval Monday using the accelerated approval pathway.

Under this pathway, the agency approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug's clinical benefit.

"We are well-aware of the attention surrounding this approval," the FDA wrote in a statement explaining the decision. "We understand that Aduhelm has garnered the attention of the press, the Alzheimer's patient community, our elected officials, and other interested stakeholders. With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review."

"At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward," the agency added.

Aducanumab, a monoclonal antibody that…
Judy George
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