Eli Lilly and Company announced that the European Commission (EC) has granted marketing authorization for Kisunla (donanemab) for adults with early symptomatic Alzheimer’s disease (AD)—those with mild cognitive impairment or mild dementia and confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriers.
Key Takeaways
- Clinical Impact: Kisunla significantly slows cognitive and functional decline, according to the phase 3 TRAILBLAZER-ALZ 2 study. Early diagnosis and treatment lead to the best outcomes.
- Mechanism: Kisunla targets amyloid plaques in the brain, helping reduce memory and thinking issues and preserving daily living activities.
- Treatment Advantage: The once-monthly infusion allows therapy completion once amyloid levels are minimal, potentially reducing costs and infusion burden.
- Safety: Side effects may include amyloid-related imaging abnormalities (ARIA-E and ARIA-H). Gradual titration schedules from the TRAILBLAZER-ALZ 6 study reduce ARIA-E risk while maintaining amyloid reduction.
Alzheimer’s Disease Context
- Prevalence: ~6.9 million people in Europe currently live with Alzheimer’s; numbers are expected to nearly double by 2050.
- Progression: About one-third of early symptomatic patients progress to advanced disease within one year.
Clinical Evidence
- TRAILBLAZER-ALZ 2: Phase 3, double-blind, placebo-controlled, 1,736 participants over 18 months. Showed significant slowing of cognitive and functional decline.
- TRAILBLAZER-ALZ 6: Phase 3b study on dosing regimens and ARIA-E incidence, enrolling 843 participants aged 60–85. Demonstrated safer, gradual titration schedules.
- Ongoing studies: TRAILBLAZER-ALZ 3 (preclinical AD) and TRAILBLAZER-ALZ 5 (registration trial in Asia).
Global Availability
Kisunla is already marketed in the US, Japan, China, UK, UAE, Qatar, Kuwait, Bahrain, Singapore, Taiwan, Brazil, Mexico, and Australia. In the EU, approval is limited to ApoE4 heterozygotes or non-carriers.
Lilly’s Commitment
Eli Lilly continues to turn science into healing, pioneering treatments for nearly 150 years, helping tens of millions globally. Kisunla’s EU approval provides hope and more time for patients to focus on what matters most.
