FDA signals relatively clear path ahead for Alzheimer’s therapy aducanumab

FDA appears to be leaning toward approval of the first theoretically disease-modifying therapy for Alzheimer’s disease, or any neurodegenerative disorder, based on two incomplete Phase III trials, one of which met its primary endpoint with modeling of the missing data, and another that failed to show even a trend toward significance.

Materials released ahead of Friday’s advisory committee meeting to discuss the anti-amyloid therapy aducanumab reveal that FDA’s interpretation of the data aligns with the arguments from Biogen Inc. (NASDAQ:BIIB) on nearly all the major issues critics have raised about the mAb’s efficacy. ...