Biogen Gets ‘Almost Shockingly Broad’ Label For Alzheimer’s Drug Aducanumab

US FDA’s Peter Stein says drug’s mechanism of action is relevant to all stages of Alzheimer’s disease. While clinical trials enrolled only those with mild disease as indicated on a PET scan, labeling has no limitations on use of Aduhelm. An FDA advisory committee member resigns from the panel in response to the approval.

The labeling for Biogen, Inc. and Eisai Co., Ltd.’s Aduhelm (aducanumab) came as a big surprise to those awaiting US Food and Drug Administration action on the drug as it does not limit use to those showing early symptoms from Alzheimer’s disease or require pre-screening of patients, conditions that had to be met for participants in two Phase III clinical trials for the drug.

The label states that Aduhelm “is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.” The indication...

Biogen Gets ‘Almost Shockingly Broad’ Label For Alzheimer’s Drug Aducanumab

More from Approval Standards

More from Pathways & Standards