In June of 2021, the US Food and Drug Administration (FDA) granted landmark approval to aducanumab – a biopharmaceutical developed by Biogen, targeted to treat Alzheimer’s disease (AD). AD is the most common form of dementia, hallmarked by progressive cognitive decline and memory loss.
Historically, AD therapies have focused on alleviating the symptoms rather than targeting the root cause of the disease. Aducanumab, however, is the first approved drug that could tackle one of the putative pathogenetic pathways of AD: the formation of amyloid-β plaques in the brain. Nevertheless, is this truly the root cause of AD? And was the aducanumab trial data robust enough to warrant FDA approval? Questions such as these fuel the controversy within the scientific community.