Lilly's Kisunla (donanemab) receives marketing authorization by European Commission for the treatment of early symptomatic Alzheimer's disease
Eli Lilly (NYSE:LLY) has received European Commission marketing authorization for Kisunla (donanemab) to treat early symptomatic Alzheimer's disease. The approval covers adults with mild cognitive impairment and mild dementia stages with confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriers.
Kisunla, administered monthly, is the only therapy that supports completing treatment once amyloid plaques reach minimal levels. The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated significant slowing of cognitive and functional decline. The drug helps remove excessive amyloid plaque buildup in the brain, potentially preserving cognitive function and independence longer.
The approval is particularly significant as Alzheimer's affects 6.9 million people in Europe, with numbers expected to double by 2050. The treatment showed effectiveness in reducing disease progression risk over 18 months, with earlier treatment yielding better responses.
Eli Lilly (NYSE:LLY) ha ottenuto l'autorizzazione all'immissione in commercio dalla Commissione europea per Kisunla (donanemab) per trattare la malattia di Alzheimer in fase iniziale con sintomi. L'approvazione riguarda adulti con compromissione cognitiva lieve e stadi di demenza lieve con patologia amyloide confermata che siano eterozigoti ApoE4 o non portatori.
Kisunla, somministrata mensilmente, è l'unica terapia che sostiene il completamento del trattamento una volta che le placche di amyloide raggiungono livelli minimi. Lo studio di fase 3 TRAILBLAZER-ALZ 2 ha dimostrato un rallentamento significativo del declino cognitivo e funzionale. Il farmaco aiuta a rimuovere l'eccessivo accumulo di placche di amiloide nel cervello, potenzialmente mantenendo la funzione cognitiva e l'indipendenza più a lungo.
L'approvazione è particolarmente significativa poiché L'Alzheimer colpisce 6,9 milioni di persone in Europa, con i numeri che dovrebbero raddoppiare entro il 2050. Il trattamento ha mostrato efficacia nel ridurre il rischio di progressione della malattia nel corso di 18 mesi, con una risposta migliore se il trattamento viene avviato prima.
Eli Lilly (NYSE:LLY) ha recibido la autorización de comercialización de la Comisión Europea para Kisunla (donanemab) para tratar la enfermedad de Alzheimer en sus etapas iniciales con síntomas. La aprobación abarca a adultos con deterioro cognitivo leve y fases leves de demencia con patología amiloide confirmada que sean heterocigotos ApoE4 o no portadores.
Kisunla, administrada mensualmente, es la única terapia que apoya completar el tratamiento una vez que las placas de amiloide alcancen niveles mínimos. El estudio de fase 3 TRAILBLAZER-ALZ 2 demostró una ralentización significativa del deterioro cognitivo y funcional. El fármaco ayuda a eliminar el exceso de acumulación de placas amiloides en el cerebro, potencialmente conservando la función cognitiva y la independencia durante más tiempo.
La aprobación es especialmente significativa ya que la enfermedad de Alzheimer afecta a 6,9 millones de personas en Europa, con proyecciones de que ese número se duplique para 2050. El tratamiento mostró eficacia en reducir el riesgo de progresión de la enfermedad en 18 meses, con mejores respuestas cuando se inicia el tratamiento de forma temprana.
Eli Lilly (NYSE:LLY)가 아일랜드 유럽 위원회(European Commission)로부터 초기 증상 알츠하이머 병 치료를 위한 Kisunla (donanemab)의 판매 허가를 받았습니다. 이번 승인은 확진된 아밀로이드 병리학을 가진 경도 인지 장애 및 경도 치매 단계의 성인 중 ApoE4 이형접합자이거나 비보유자에게 해당합니다.
Kisunla은 매월 투여되며 아밀로이드 플라크가 최소 수준에 도달했을 때 치료를 완료하도록 돕는 유일한 치료제입니다. 3상 TRAILBLAZER-ALZ 2 연구에서 인지 및 기능 저하의 현저한 둔화가 입증되었습니다. 이 약은 뇌 속 과도한 아밀로이드 플라크 축적을 제거하는 데 도움을 주어 인지 기능과 자립을 더 오래 보전할 가능성이 있습니다.
이번 승인은 유럽에서 알츠하이머가 690만 명에 영향을 준다는 점에서 특히 의미가 크며, 2050년까지 그 수가 두 배로 늘어날 것으로 예측됩니다. 이 치료는 18개월 동안 질병 진행 위험을 감소시키는 효과를 보였고, 일찍 치료를 시작할수록 더 나은 반응이 나타났습니다.
Eli Lilly (NYSE:LLY) a reçu l'autorisation de mise sur le marché de la Commission européenne pour Kisunla (donanemab) en vue de traiter la maladie d'Alzheimer à ses débuts symptomatiques. L'approbation concerne les adultes présentant un déclin cognitif léger et des stades de démence légère avec une pathologie amyloïde confirmée, qui sont des hétérozygotes ApoE4 ou des non-porteurs.
Kisunla, administré mensuellement, est la seule thérapie qui permet de terminer le traitement une fois que les plaques amyloïdes atteignent des niveaux minimaux. L'étude de phase 3 TRAILBLAZER-ALZ 2 a démontré un ralentissement significatif du déclin cognitif et fonctionnel. Le médicament aide à éliminer l'excès d'accumulation de plaques amyloïdes dans le cerveau, ce qui pourrait préserver la fonction cognitive et l'autonomie plus longtemps.
Cette approbation est particulièrement significative car la maladie d'Alzheimer touche 6,9 millions de personnes en Europe, et ce chiffre devrait doubler d'ici 2050. Le traitement a montré son efficacité à réduire le risque de progression de la maladie sur 18 mois, avec de meilleures réponses lorsque le traitement est initié plus tôt.
Eli Lilly (NYSE:LLY) hat von der Europäischen Kommission die Marktzulassung für Kisunla (donanemab) zur Behandlung der frühen, symptomatischen Alzheimer-Krankheit erhalten. Die Zulassung gilt für Erwachsene mit leichtem kognitivem Abbau und leichten Demenzstadien mit bestätigter Amyloid-Pathologie, die ApoE4-Heterozygote oder Nicht-Träger sind.
Kisunla, das monatlich verabreicht wird, ist die einzige Therapie, die eine Behandlung nach Erreichen minimaler Amyloid-Plaques unterstützt. Die Phase-3-Studie TRAILBLAZER-ALZ 2 zeigte eine signifikante Verlangsamung des kognitiven und funktionalen Verfalls. Das Medikament hilft, eine übermäßige Ansammlung von Amyloid-Plaques im Gehirn zu entfernen, was potenziell die kognitive Funktion und Unabhängigkeit länger erhält.
Die Zulassung ist besonders bedeutsam, da Alzheimer Europaweit 6,9 Millionen Menschen betrifft, wobei die Zahlen bis 2050 voraussichtlich verdoppelt werden. Die Behandlung zeigte eine Wirksamkeit bei der Reduktion des Risikos für Krankheitsprogression über 18 Monate, wobei frühere Behandlung bessere Reaktionen erzielte.
إيلي ليلي (المِخْتَزلة: LLY) حصلت على ترخيص تسويق من المفوضية الأوروبية لـ Kisunla (donanemab) لعلاج مرض الزهايمر في مراحله المبكرة المصحوبة بأعراض. يشمل الترخيص بالغين يعانون من انخفاض إدراكي خفيف ومرحلة خَرَف خفيف مع وجود مرض أميلويد مؤكد، وهم حاملو ApoE4 من النمط الوراثي أو غير حامليها.
Kisunla، المٌعطى شهرياً، هو الدواء الوحيد الذي يدعم استكمال العلاج بمجرد وصول لُبس الأميلويد إلى مستويات دنيا. أظهرت دراسة المرحلة الثالثة TRAILBLAZER-ALZ 2 تباطؤاً ملحوظاً في التدهور المعرفي والوظيفي. يساعد الدواء في إزالة تراكم المريء الزائد من لُبَة الأميلويد في الدماغ، مما قد يحفظ الوظائف الإدراكية والاستقلالية لفترة أطول.
يكتسب الترخيص أهمية خاصة إذ أن مرض الزهايمر يؤثر على 6.9 ملايين شخص في أوروبا، ومن المتوقع أن يتضاعف العدد بحلول 2050. أظهرت المعالجة فاعلية في تقليل خطر تقدم المرض على مدى 18 شهراً، مع استجابة أفضل إذا بدأ العلاج مبكراً.
礼来（NYSE:LLY） 已获得欧洲委员会对 Kisunla（donanemab） 的上市许可，用于治疗早期症状性阿尔茨海默病。该批准覆盖患有轻度认知障碍和轻度痴呆阶段、且证实为淀粉样蛋白病理、为 ApoE4 杂合子或非携带者的成人。
Kisunla 每月给药，是 唯一在淀粉样斑块达到最少水平时支持完成治疗的疗法。3期 TRAILBLAZER-ALZ 2 研究显示在认知和功能衰退方面有显著放缓。该药物有助于清除大脑中过量的淀粉样斑块积累，可能更久地维持认知功能与独立性。
此次批准尤为重要，因为 阿尔茨海默病在欧洲影响约690万人，预计到2050年这一数字将翻倍。该治疗在18个月内显示出降低疾病进展风险的效果，越早治疗效果越好。
- First therapy allowing treatment completion once amyloid plaques reach minimal levels
- Demonstrated significant slowing of cognitive and functional decline in Phase 3 trials
- Monthly dosing schedule may reduce infusion burden and treatment costs
- Significantly reduces risk of disease progression over 18 months
- New gradual titration dosing schedule showed lower ARIA-E incidence while maintaining efficacy
- Limited to specific patient population (ApoE4 heterozygotes or non-carriers)
- Risk of serious ARIA side effects, which can be potentially fatal
- Higher ARIA risk for ApoE4 gene carriers
Insights
Lilly's Kisunla approval in Europe marks significant breakthrough in Alzheimer's treatment with completion pathway and proven efficacy.
The European Commission's marketing authorization for Lilly's Kisunla (donanemab) represents a significant milestone in the Alzheimer's disease treatment landscape. What differentiates Kisunla from existing therapies is its unique treatment protocol - the only therapy with evidence supporting a completion of treatment once amyloid plaques are reduced to minimal levels. This approach could substantially reduce the infusion burden and treatment costs compared to indefinite treatment regimens.
The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated that Kisunla significantly slowed cognitive and functional decline in early symptomatic Alzheimer's patients. More impressively, data shows Kisunla reduced the risk of disease progression to more advanced stages over 18 months. The approval specifically targets adults with mild cognitive impairment and mild dementia stages with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers.
The addressable market is substantial - Alzheimer's currently affects approximately 6.9 million Europeans, projected to nearly double by 2050. The timing is critical as approximately one-third of individuals in early symptomatic stages progress to advanced stages within one year, highlighting the urgent need for early intervention.
The approval includes a modified dosing schedule based on the Phase 3b TRAILBLAZER-ALZ 6 study, which demonstrated lower incidence of Amyloid-related imaging abnormalities (ARIA-E) with a more gradual titration approach while maintaining efficacy in amyloid plaque removal and P-tau217 reduction. This represents an important safety optimization that could improve the therapy's risk-benefit profile.
Approved for earliest symptomatic stages of disease, demonstrating significant slowing of cognitive and functional decline
Only therapy with evidence to support completing course of treatment once amyloid plaques are reduced to minimal levels
"Kisunla demonstrated meaningful results in people with early symptomatic Alzheimer's disease by significantly slowing cognitive and functional decline in our Phase 3 TRAILBLAZER-ALZ 2 study," said Patrik Jonsson, executive vice president and president of Lilly International. "The data shows that the earlier patients are identified, diagnosed, and treated with Kisunla, the greater the response to treatment. This authorization brings a new option to patients in Europe—offering hope and the potential for more time to focus on what matters most."
Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques.1,2 The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer's disease. Kisunla can help the body remove the excessive buildup of amyloid plaques and slow the decline that may diminish people's ability to: remember new information, important dates and appointments; plan and organize; make meals; use household appliances; manage finances; and be left alone.1-3
Kisunla is the only once-monthly amyloid plaque-targeting therapy with evidence supporting completing course of treatment once amyloid is reduced to minimal levels. This may reduce infusion burden and treatment costs. Treatment with Kisunla slows disease progression which may help preserve cognitive function and independence longer.4-7 Data has also shown that Kisunla can significantly reduce the risk of progressing to the next clinical stage of disease over 18 months.4,8
Alzheimer's disease currently affects as many as 6.9 million people in Europe, with this figure expected to almost double by 2050 as aging populations continue to increase.9,10 Alzheimer's disease progresses in stages that increase in severity over time, resulting in loss of independence and ability to care for oneself. There is an urgent need for detection, referral to specialists, diagnosis and treatment at the earliest stages of Alzheimer's disease as approximately one-third of individuals in early symptomatic stages of the disease will progress to more advanced clinical stages within one year.11
The Kisunla marketing authorization in the European Union is based on the TRAILBLAZER-ALZ 2 and the TRAILBLAZER-ALZ 6 clinical trials. The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated Kisunla significantly slowed cognitive and functional decline.4,8 Cognitive and functional decline involves greater memory and thinking problems, affecting daily activities and needing more caregiver support.4,12
Amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and with hemorrhage/ hemosiderosis (ARIA-H) are side effects within the class of therapies that do not usually cause any symptoms, but serious and life-threatening symptoms can occur. ARIA can be fatal. Carriers of one or two copies of the ApoE4 gene may be at higher risk of developing Alzheimer's disease and experiencing ARIA. Patients should discuss any safety concerns with their healthcare providers.
The dosing schedule is based on the Phase 3b TRAILBLAZER-ALZ 6 study, which demonstrated that the incidence of ARIA-E was significantly lowered at 24 and 52 weeks using a more gradual titration dosing schedule versus the dosing schedule used in TRAILBLAZER-ALZ 2. This gradual dosing increase still achieved similar levels of amyloid plaque removal and P-tau217 reduction.8
About Kisunla
Donanemab, a monthly infusion, is currently marketed as Kisunla in the United States and other countries, including Japan, China, United Kingdom,
*Donanemab is branded as Lormalzi in
About TRAILBLAZER-ALZ 2
TRAILBLAZER-ALZ 2 (NCT04437511) was a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab over 18 months in participants with early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia due to Alzheimer's disease) with the presence of confirmed Alzheimer's disease neuropathology. The trial enrolled 1,736 participants, across 8 countries, selected based on cognitive assessments in conjunction with evidence of Alzheimer's disease pathology. The Phase 3 TRAILBLAZER-ALZ 2 study results were published in the Journal of the American Medical Association (JAMA).
About TRAILBLAZER-ALZ 6 study and the TRAILBLAZER-ALZ program
TRAILBLAZER-ALZ 6 (NCT05738486) was a Phase 3b, multicenter, randomized, double-blind study to investigate different dosing regimens and their effect on ARIA-E in adults with early symptomatic Alzheimer's disease. The trial enrolled 843 participants ages 60-85 selected based on cognitive assessments in conjunction with amyloid plaque imaging by PET scan. The primary endpoint results were published in Alzheimer's and Dementia.
Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, which is evaluating the safety and efficacy of donanemab in patients with preclinical Alzheimer's disease (Stage 1 and 2) to determine if it reduces risk of progression to symptomatic Alzheimer's disease. TRAILBLAZER-ALZ 5 is a registration trial for early symptomatic Alzheimer's disease currently enrolling in China, Korea, Taiwan, and other geographies.
Kisunla (donanemab-azbt), pronounced kih-SUHN-lah, is used to treat adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease.
Warnings - Kisunla can cause Amyloid-Related Imaging Abnormalities or "ARIA." This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Although most people do not have symptoms, some people have headaches, dizziness, nausea, difficulty walking, confusion, vision changes and seizures.
Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor.
You may be at higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla. Talk to your healthcare provider to see if you are on any medicines that increase this risk.
Your healthcare provider will do magnetic resonance imaging (MRI) brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms.
Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.
There are registries that collect information on treatments for Alzheimer's disease. Your healthcare provider can help you become enrolled in these registries.
Warnings - Kisunla can cause serious allergic and infusion-related reactions. Do not receive Kisunla if you have serious allergic reactions to donanemab-azbt or any of the ingredients in Kisunla. Symptoms may include swelling of the face, lips, mouth, or eyelids, problems breathing, hives, chills, irritation of skin, nausea, vomiting, sweating, headache, or chest pain. You will be monitored for at least 30 minutes after you receive Kisunla for any reaction. Tell your healthcare provider right away if you have these symptoms or any reaction during or after a Kisunla infusion.
Other common side effects
- Headache
Tell your healthcare provider right away if you have any side effects. These are not all of the possible side effects of Kisunla. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before you receive Kisunla, tell your healthcare provider:
- About all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements. Especially tell your healthcare provider if you have medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin).
- About all of your medical conditions including if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Kisunla has not been studied in people who were pregnant or breastfeeding. It is not known if Kisunla could harm your unborn or breastfeeding baby.
How to receive Kisunla
Kisunla is a prescription medicine given through an intravenous (IV) infusion using a needle inserted into a vein in your arm. Kisunla is given once every 4 weeks. Each infusion will last about 30 minutes.
Learn more
For more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or go to kisunla.lilly.com.
This summary provides basic information about Kisunla. It does not include all information known about this medicine. Read the information given to you about Kisunla. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Kisunla. Your healthcare provider is the best person to help you decide if Kisunla is right for you.
Please see full Prescribing Information including boxed warning for ARIA and Medication Guide for Kisunla.
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About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Kisunla (donanemab-azbt) as a treatment for people with early symptomatic Alzheimer's disease, the supply and commercialization of Kisunla, and future readouts, presentations, and other milestones relating to Kisunla and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study findings to date, that Kisunla will receive additional regulatory approvals or that Kisunla will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
References:
- Porsteinsson AP, Isaacson RS, Knox S, et al. Diagnosis of early Alzheimer's disease: clinical practice in 2021. J Prev Alzheimers Dis. 2021;8:371-386.
- Alzheimer's Association. 2023 Alzheimer's disease facts and figures. Alzheimers Dement. 2023;19(4):1598-1695
- Wessels AM, Dennehy EB, Dowsett SA, et al. Meaningful clinical changes in Alzheimer disease measured with the iADRS and illustrated using the donanemab TRAILBLAZER-ALZ study findings. Neurol Clin Pract. 2023;13(2):e200127. doi:10.1212/CPJ.0000000000200127
- Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023;330(6):512-527. doi:10.1001/jama.2023.13239.
- Ross EL, Weinberg MS, Arnold SE. Cost-effectiveness of Aducanumab and Donanemab for Early Alzheimer Disease in the US. JAMA Neurol. 2022;79(5):478-487. doi:10.1001/jamaneurol.2022.0315.
- Boustani M, Doty EG, Garrison LP Jr, et al. Assessing the Cost-effectiveness of a Hypothetical Disease-modifying Therapy With Limited Duration for the Treatment of Early Symptomatic Alzheimer Disease. Clin Ther. 2022;44(11):1449-1462. doi:10.1016/j.clinthera.2022.09.008.
- Mattke S, Ozawa T and Hanson M. Implications of Treatment Duration and Intensity on the Value of Alzheimer's Treatments. Clinical Trials on Alzheimer's Disease. Oct. 24-27, 2023.
- Wang H, Monkul Nery ES, Ardayfio P, et al. (2025). 21(4). https://doi.org/10.1002/alz.70062
- Gustavsson, A., et al. Global estimates on the number of persons across the Alzheimer's disease continuum. Alzheimer's & Dementia. 2023;19:658-670. https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12694.
- Alzheimer Europe. Prevalence of dementia in
Europe . Available at: https://www.alzheimer-europe.org/dementia/prevalence-dementia-europe. - Potashman M, Buessing M, Levitchi Benea M, et al. Estimating progression rates across the spectrum of Alzheimer's disease for amyloid-positive individuals using national Alzheimer's coordinating center data. Neurol Ther. 2021;10(2):941-953. doi:10.1007/s40120-021-00272-1
- Alzheimer's Association. 2025 Alzheimer's disease facts and figures. Alzheimer's Dement. 2025;21(4):1600–1705.
Refer to:
Gina Goodenough, gina.goodenough@lilly.com; 463-304-2167 (Media)
Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors)
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