Donanemab receives favorable decision from the EMA for treatment in early stages of Alzheimer's disease
The European Medicines Agency (EMA) has recommended granting a marketing authorization for Kisunla (donanemab) to treat early Alzheimer's disease in adults who either have no copies or only one copy of the ApoE4 gene. This recommendation, if approved by the European Commission, could mark a significant step in the fight against Alzheimer's disease.
Currently, Alzheimer's disease affects 6.9 million people in Europe and is expected to nearly double by 2050 due to the aging population. Approximately one-third of people with mild cognitive impairment or mild dementia due to Alzheimer's disease progress to the next clinical stage within a year.
Donanemab has shown promising results in slowing cognitive and functional decline in symptomatic early-stage Alzheimer's disease patients, as demonstrated in the TRAILBLAZER-ALZ 2 clinical trial. The drug targets amyloid plaques, a key characteristic of Alzheimer's disease, and has the potential to make a significant difference in the lives of those affected.
Initially, in March 2025, EMA refused authorization for Kisunla due to concerns that the risks of ARIA (ARIA-E and ARIA-H) outweighed the benefits. However, Eli Lilly appealed this decision, citing precedent from a successful appeal for a similar Alzheimer's drug, Leqembi. On 24 July 2025, EMA reversed its position for a subset of patients (noncarriers or heterozygotes of ApoE4) and recommended approval.
The recommendation now moves to the European Commission, which is expected to make a final regulatory decision in the coming months. If approved, Kisunla will be targeted for early Alzheimer's patients without or with only one ApoE4 gene copy due to safety concerns related to ARIA.
Patrik Jonsson, the executive vice president and president of Lilly International, stated that this positive opinion is a significant milestone in their efforts to bring donanemab to patients across Europe. José Antonio Sacristán, medical director of Lilly Spain, emphasized the health and social consequences of Alzheimer's disease and the need for enhanced capabilities in early diagnosis, access to biomarkers, and multidisciplinary teams in the healthcare system.
Donanemab is administered via infusion once a month. It is currently marketed in various countries, including the United States, United Kingdom, Japan, and Singapore, among others.
In conclusion, the positive opinion from the EMA for Kisunla (donanemab) is a promising development in the treatment of early-stage Alzheimer's disease. If approved by the European Commission, it will provide a new treatment option for those with a lower genetic risk of ARIA related to ApoE4 status. This could potentially change the course of Alzheimer's disease in its early stages, offering hope to millions of Europeans affected by this debilitating disease.
[1] European Medicines Agency. (2025). EMA recommends granting marketing authorisation for Kisunla (donanemab) for the treatment of Alzheimer's disease. Retrieved from https://www.ema.europa.eu/en/news/ema-recommends-granting-marketing-authorisation-kisunla-donanemab-treatment-alzheimers-disease
[2] Eli Lilly and Company. (2025). EMA Recommends Marketing Authorisation for Kisunla (donanemab) for the Treatment of Early Alzheimer's Disease. Retrieved from https://www.lilly.com/news/press-releases/ema-recommends-marketing-authorisation-for-kisunla-donanemab-for-the-treatment-of-early-alzheimers-disease
[3] Alzheimer's Research UK. (2025). EMA recommends donanemab (Kisunla) for Alzheimer's disease. Retrieved from https://www.alzheimersresearchuk.org/about-us/news-and-events/ema-recommends-donanemab-kisunla-for-alzheimers-disease
[4] European Commission. (2025). Overview of the regulatory process. Retrieved from https://ec.europa.eu/health/documents/community-register/regulatory_process_en.pdf
[5] European Medicines Agency. (2025). Overview of the regulatory process. Retrieved from https://www.ema.europa.eu/en/human-regulatory/overview-regulatory-process
- The recommendation for Kisunla (donanemab) by the European Medicines Agency (EMA) marks a significant step in the intersection of science and fashionable health-and-wellness trends, as it represents a novel advancement in the treatment of early Alzheimer's disease.
- Neurological disorders, such as Alzheimer's disease, have a profound impact on both mental health and general health-and-wellbeing, and innovative treatments like donanemab potentially offer a glimmer of hope for those affected by these medical-conditions.
- The EMA's recommendation for donanemab also signifies a shift in the landscape of science and healthcare, with the potential to improve early diagnosis and management of Alzheimer's disease, potentially benefiting millions across Europe.
