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    Alzheimer’s Association Welcomes European Medicines Agency Committee’s Decision to Recommend Kisunla for the Treatment of Alzheimer’s Disease

    Alzheimer’s Association Welcomes European Medicines Agency Committee’s Decision to Recommend Kisunla for the Treatment of Alzheimer’s Disease

    CHICAGO, July 25, 2025 — The Alzheimer’s Association welcomes the decision by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to recommend marketing authorization for Kisunla® (donanemab) for the treatment of early symptomatic Alzheimer’s disease. This recommendation reverses the previous negative opinion issued earlier this year.

    “We are encouraged by the revised recommendation for Kisunla,” said Joanne Pike, DrPH, president and CEO of the Alzheimer’s Association. “This decision reflects a deeper understanding of the scientific evidence and is a vital step toward ensuring individuals across Europe have choices in treatment options for early Alzheimer’s disease.”

    In issuing its revised statement, CHMP determined that donanemab is indicated in a more restricted population — individuals with only one copy of Apoe4 or those without the risk gene. The Alzheimer’s Association disagrees with the decision to exclude this patient population from the eligible treatment pool and encourages the EMA to continue to review clinical trials and real world evidence and expand their recommendation.

    Following this positive recommendation from the CHMP, the European Commission will make the final decision on marketing authorization for Kisunla across the European Union. The Alzheimer’s Association urges the European Commission to swiftly approve Kisunla, bringing this much-needed treatment to eligible patients in Europe.

    This news comes as the global dementia research community gathers in Toronto and online for the Alzheimer’s Association International Conference® (AAIC) where new findings on real-world evidence of approved treatments and insights on the next generation of treatments will be reported. It is a moment of hope and progress for the field and for people living with the disease.

    About the Alzheimer's Association

    The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit alz.org or call 800.272.3900.