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Lilly raises the bar in Alzheimer’s, but complicates path to approval

ARTICLE | Regulation

FDA’s questions for advisory committee center on patient subgroups, and whether and when to end amyloid mAb treatment

By Selina Koch, Executive Editor

June 7, 2024 12:59 AM UTC

Eli Lilly’s sophisticated clinical trial design, though highly informative for the Alzheimer’s disease field, has complicated the interpretation and review of its anti-amyloid therapy donanemab.

Up for discussion at Monday’s advisory committee meeting is not whether the anti-amyloid mAb from  Eli Lilly and Co. (NYSE:LLY) is effective, but in which subgroups of patients it has a positive risk-benefit profile. The treatment may be effective in certain patients who were not included in the trial, based on what’s known about the disease biology and drug mechanism. On the other hand, there was a subgroup of patients in the trial who clearly received much less benefit than others, calling into question the risk-benefit profile in the subgroup — especially given the serious safety risks of the anti-amyloid drug class.