On September 25, 2025, Eli Lilly announced that the European Commission granted marketing authorization for Kisunla (donanemab) for early symptomatic Alzheimer’s disease, covering mild cognitive impairment and mild dementia with confirmed amyloid pathology. The approval applies to patients who are apolipoprotein E (ApoE4) heterozygotes or non‑carriers.
The decision follows Phase 3 TRAILBLAZER‑ALZ 2 data showing significant slowing of cognitive and functional decline, with the drug demonstrating meaningful benefit in patients with early symptomatic disease. Kisunla is the first amyloid‑targeting therapy with evidence supporting a complete course of treatment once amyloid plaques are reduced to minimal levels, potentially reducing infusion burden and treatment costs.
The European Commission approval expands Lilly’s Alzheimer’s portfolio into the EU market, providing access to a large patient population and strengthening its position against competitors such as Eli Lilly’s earlier approvals in the U.S. and Japan. The authorization is expected to generate new revenue streams and support Lilly’s long‑term growth strategy in neuroscience.
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