Aducanumab’s approval doesn’t change plans for late-stage AD programs
But it does provide a fallback option of accelerated approval if cognitive data are unclear
FDA’s decision to approve aducanumab based on the surrogate marker of β-amyloid reduction won’t change the conduct of several late-stage Alzheimer’s trials. But it does set a precedent of a fallback option should the data on clinical benefit be uncertain.
At least three mAbs targeting β-amyloid expect to read out Phase III data by year-end 2022 with a fourth, donanemab from Eli Lilly & Co. (NYSE:LLY) expected to report in 2023...