Lilly’s Donanemab Tops Aduhelm in Study

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 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.