A Review of Data Supporting the Approval of Aducanumab for Alzheimer Disease

Findings from the 2 pivotal phase 3 trials had mixed results on cognitive benefit, although they found a positive reduction in amyloid plaque in patients' brains.

In an interview with Pharmacy Times, Pamela Spicer, senior analyst at Datamonitor with Informa Pharma Intelligence, reviewed the 2 pivotal phase 3 clinical trials supporting the FDA's recent approval of aducanumab. Notably, Spicer said 1 trial had a positive trend while the second trial had a negative trend, which resulted in the early cessation of both trials.

The findings had mixed results on cognitive benefit, although they found a positive reduction in amyloid plaque in patients' brains. Based on this, officials with the FDA approved the drug, Spicer said.