FDA approves Biogen’s Alzheimer’s drug

The Food and Drug Administration (FDA) on Monday approved Biogen’s Alzheimer’s drug, marking the first new authorized therapy to treat the disease in nearly two decades. The drug, Aduhelm (aducanumab), had received mixed reviews following earlier clinical trials.

In a statement following the approval, Dr. Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said the agency used the Accelerated Approval pathway, which is when 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."