FDA Approves Biogen’s Aduhelm, A New Treatment For Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) approved Aduhelm (aducanumab) developed by Biogen Inc. to treat people with Alzheimer’s disease. The approval was through the FDA’s Accelerated Approval pathway, under which the FDA 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.

Aduhelm, a human monoclonal antibody, is the first novel therapy . . .