European Commission Grants Marketing Authorization for Lilly’s Kisunla (donanemab) for the Treatment of Early Alzheimer’s Disease

Eli Lilly and Company

Eli Lilly and Company announced the European Commission has granted marketing authorization for Kisunla (donanemab) to treat early symptomatic Alzheimer’s disease. The therapy demonstrated a significant slowing of cognitive and functional decline and is unique for supporting a finite treatment course.

Lilly’s Kisunla (Donanemab) Shows Long-Term Benefit in Treating Early Alzheimer’s Disease

Eli Lilly and Company

Eli Lilly and Company announced results from the long-term extension of the Phase 3 TRAILBLAZER-ALZ 2 study, demonstrating that participants treated with Kisunla (donanemab-azbt) for early symptomatic Alzheimer’s disease showed a continued slowing of decline over three years.

FDA Approves Updated Label for Lilly’s Alzheimer’s Drug Kisunla (donanemab-azbt), Offering a Safer Dosing Schedule

Eli Lilly and Company

The U.S. Food and Drug Administration (FDA) has officially approved an updated label for Eli Lilly’s groundbreaking Alzheimer’s drug, Kisunla (donanemab-azbt). This significant update introduces a new, more gradual dosing schedule specifically designed to enhance patient safety by reducing the risk of amyloid-related imaging abnormalities (ARIA), a critical side effect.