July 25, 2025 –European Medicines Agency (AMA) reversed its initial decision by recommending approval of Eli Lilly’s Kisunla for certain patients with Alzheimer’s disease. This marks a big change in how Alzheimer’s treatments are approved in Europe.
In March 2025, EMA rejected Eli Lilly’s Alzheimer’s drug Kisunla (donanemab). The regulatory body cited that Kisunal’s marginal cognitive benefits did not justify the risk of serious brain swelling and bleeding.
However, after Eli Lilly requested a re-examination as well as provided additional data, the CHMP reversed its decision. It issued a restricted recommendation in favor of approving Kisunla, but only for patients with zero or one copy of the ApoE4 gene.
The positive opinion was based on TRAILBLAZER-ALZ 2 trial results showing donanemab significantly slowed cognitive decline as well as disease progression. It also considered TRAILBLAZER-ALZ 6 findings on a modified dosing schedule.
Views and Statements
Speaking on the occasion, Patrik Johnson, executive vice president and president of Lilly International, said, “This positive opinion represents a major step forward in our mission to make donanemab available to eligible patients throughout Europe.”
He further added, “Donanemab shows promise for early Alzheimer's treatment, and Lilly remains dedicated to advancing research through ongoing trials.” Once approved, Kisunla could set a new standard of care for patients with Alzheimer’s disease across Europe.
Alzheimer's disease currently impacts up to 6.9 million people in Europe. This number is projected to nearly double by 2050 due to the growing geriatric population. To tackle this burden, Donanemab could play an essential role in the coming years.
Impact and Future Outlook
The European Commission is expected to issue a regulatory decision on Kisunla in the coming months, says Eli Lilly. If approved, Kisunla could become the second amyloid‑targeting therapy available in the EU after Eisai/Biogen's Leqembi.
Lilly's Kisunla is expected to enhance access to effective Alzheimer's treatments across Europe. The company also plans to increase Kisunla (donanemab) sales through the new expansion. Kisunla's projected peak sales are expected to reach the billions annually.
Eli Lilly’s success in gaining EMA backing for Kisunla marks a pivotal moment. It signals renewed regulatory openness to precision-treated, risk-managed Alzheimer’s drugs. This will likely encourage greater biomarker-driven diagnosis and early intervention.
The approval will also catalyze growth and competition in a previously stagnant therapeutic class. Other companies are expected to follow Lilly’s suit by entering lucrative markets like Europe and the United States with high Alzheimer’s patient pool. This will eventually boost growth of the global Alzheimer’s drugs industry during the forthcoming period.
Sources:
News Outlet: Reuters
Company: Eli Lilly and Company