Donanemab receives positive opinion from CHMP

Posted on 28 July, 2025 - Alzheimer's Disease, Dementia

The opinion will now be referred to the European Commission for final regulatory decision 

 25 July 2025: Eli Lilly and Company announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending donanemab for the treatment of early symptomatic Alzheimer’s disease in adults with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers. This follows a re-examination of its initial opinion. The European Commission is expected to make a regulatory decision on donanemab in the coming months.

“This positive opinion marks a significant milestone in our efforts to bring donanemab to eligible patients across Europe,” said Patrik Jonsson, executive vice president and president of Lilly International. “Donanemab has the potential to make a meaningful difference for people living with early symptomatic Alzheimer’s disease, and Lilly remains committed to advancing the science through ongoing clinical trials and programs.”

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.1-2 Approximately one-third of individuals with mild cognitive impairment or mild dementia due to Alzheimer’s disease progress to the next clinical stage of disease in one year.3

The positive opinion was primarily based on clinical trial data from the TRAILBLAZER-ALZ 2 clinical trial demonstrating that donanemab significantly slowed cognitive and functional decline and reduced the risk of progressing to the next clinical stage of disease, as well as the TRAILBLAZER-ALZ 6 clinical trial which evaluated a modified titration dosing schedule.4 In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the dosing schedule used in TRAILBLAZER-ALZ 2 at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. 

Amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and with haemorrhage/ 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.

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About Kisunla
Donanemab, a monthly infusion, is currently marketed as Kisunla in the United States and other countries, including Japan, China, UK, UAE, Qatar, Kuwait, Bahrain, Singapore*, Taiwan, Brazil, Mexico and Australia. In the United States, Japan, China and many other countries, donanemab is approved for patients regardless of ApoE4 status. Donanemab is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.5-8

References

  1. 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.
  2. Alzheimer Europe. Prevalence of dementia in Europe. Available at: https://www.alzheimer-europe.org/dementia/prevalence-dementia-europe.
  3. 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
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.