Biogen’s Aducanumab First Alzheimer’s Drug Approved in Nearly 20 Years

The U.S. Food and Drug Administration (FDA) granted approval of Biogen’s aducanumab for the treatment of Alzheimer’s disease. It is the first drug approved that treats an underlying cause of the disease. It will be marketed under the trade name Aduhelm.

“We are well-aware of the attention surrounding this approval,” stated Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested shareholders. 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.”

The agency stated that it determined there was “substantial evidence” Aduhelm helped patients. “As a result of FDA’s approval of Aduhelm, patients with Alzheimer’s disease have an important and critical new treatment to help combat this disease.”

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