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# Lilly’s Donanemab Tops Aduhelm in Study
- URL: https://www.fdaweb.com/lillys-donanemab-tops-aduhelm-in-study/
- Published: 2022-12-01T12:00:00.000Z
- Updated: 2026-09-14T18:08:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153296

Lilly says its investigational Alzheimer’s drug donanemab reduced brain amyloid plaque levels versus baseline by 65.2% compared with 17% for Biogen’s Aduhelm (aducanumab-avwa) in the Phase 3 TRAILBLAZER-ALZ 4 study. A company [announcement](http://investor.lilly.com/news-releases/news-release-details/lilly-shares-positive-donanemab-data-first-active-comparator?ref=fdaweb.com) says donanemab met all primary and secondary endpoints for the six-month primary outcome analysis. It describes donanemab as an investigational antibody that targets a modified form of beta-amyloid plaque called N3pG.

The notice says the safety profile of both drugs was consistent with previously published studies, with ARIA (amyloid-related imaging abnormalities) as the most common treatment-emergent adverse effect in both groups.

The study is continuing and will have 12-month and 18-month secondary analyses, Lilly says.

FDA accepted Lilly's donanemab application for review in August with a priority review designation under the accelerated approval pathway.