FDA insider review offers a stellar endorsement for Biogen’s controversial aducanumab to treat Alzheimer’s — but statistical analysis mars the picture
The FDA just published its review of Biogen’s application for the approval of aducanumab to treat Alzheimer’s, and regulators delivered a solid endorsement for using the one positive Phase III trial for an approval, adding outcomes from a much smaller safety study to provide the additional data needed to meet the FDA’s standards for an OK.
Their conclusion: Biogen has provided “exceptionally persuasive” evidence of the drug’s efficacy. The review also dismisses safety concerns, saying they can be addressed in the label. And they waved aside a multitude of past failures for other drugs that target beta amyloid, saying that this drug is distinctly different from the rest while past trials could also have been spiked by poor design.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.