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FDA Approves Aduhelm For Alzheimer's Treatment

The U.S. Food and Drug Administration Monday granted accelerated approval to Biogen's (BIIB) Aduhelm (aducanumab) for the treatment of Alzheimer's.

Aduhelm represents a first-of-its-kind treatment approved for Alzheimer's disease. It is the first new treatment approved for Alzheimer's since 2003 and is the first therapy that targets the fundamental pathophysiology of the disease.

Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.

Alzheimer's is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually, the ability to carry out simple tasks.
Alzheimer's affects nearly 6.2 million Americans.

"Alzheimer's disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research. "Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer's. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation."

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