An Explanation of the Controversies Surrounding Aducanumab

Despite the FDA's approval of aducanumab for the treatment of Alzheimer disease with mild cognitive impairments, it has been surrounded with controversies. In an interview with Pharmacy Times, Pamela Spicer, MS, senior analyst with Datamonitor at Informa Pharma Intelligence, outlined the various concerns raised by experts, and the responses of patient advocacy groups.

Findings from 2 pivotal phase 3 trials noted decreases in amyloid plaque in the brain, although they had differing results in cognitive impairments. Based on these findings, the FDA Advisory Committee declined to approve aducanumab in 2020, although it was reconsidered and later approved in 2021 despite some experts' concerns.