Opinion: The approval of aducanumab isn’t the end of the story. It’s just the beginning
People living with Alzheimer’s dementia — the forgetfulness, the confusion, and the ultimate erasure of identity — and their families pushed hard for the Food and Drug Administration to approve aducanumab, Biogen’s drug for it. Clinicians and scientists working on Alzheimer’s were split in their opinions on its clinical benefit. The FDA’s own expert panel advised against it.
In the statement accompanying its ruling, the FDA laid out its decision to approve aducanumab based on the reduction of amyloid protein — a hallmark of Alzheimer’s disease — seen in PET scans of the brain, the biomarker used to assess effectiveness. This change was seen across both Biogen Phase 3 trials, though the high dosage resulted in less cognitive decline over time in only one of them.
