FDA’s Accelerated Approval of Alzheimer’s Drug Faces Widespread Backlash and Scrutiny

June 9, 2021

Biogen’s aducanumab drug was approved earlier this week by the Food and Drug Administration (FDA). The drug is intended for use in Alzheimer’s disease and has been shown to reduce amyloid beta plaque. However, this reduction in plaques has not been clearly shown to lead to improved clinical outcomes. Now, the drug’s accelerated approval faces immense criticism as opponents argue that the FDA bent its rules to allow the drug to be approved. Critiques claim this poor decision will lead to industry-wide consequences ranging from elevated drug costs to poor healthcare access to an overburdened Medicare system.

“From companies now digging into new post-hoc analyses of failed trials, to others that can return to searching for amyloid beta-targeted drugs in search of a similar accelerated approval — when the bar is lowered for everyone, it’s the companies that put in the hard work to truly prove their drugs are safe and effective that will be hurt.” Harvard’s Aaron Kesselheim remarks, “Accelerated Approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval.” Read more here.