Eli Lilly and Company โ Kisunla EMA EPAR public assessment report (EMEA/H/C/006024, 2025)
Eli Lilly and Company ยท 2025 ยท EMA EPAR public assessment report ยท company profile โ
Report summary
The EMA's assessment of Kisunla (donanemab) for early symptomatic Alzheimer's disease concluded with a recommendation to grant marketing authorization after a re-examination process. Donanemab, an IgG1 monoclonal antibody targeting N3pE Aฮฒ plaques, demonstrated acceptable quality and a mechanism involving microglial phagocytosis. Clinical trials showed small but statistically significant benefits in cognitive and functional scales, particularly in patients with lower tau load. However, significant safety concerns, primarily Amyloid-Related Imaging Abnormalities (ARIA-E and ARIA-H), including severe and fatal cases, were noted, especially in APOE ฮต4 carriers. Risk minimization strategies, including mandatory APOE testing, MRI monitoring, and a controlled access program, were implemented. Despite these measures, some CHMP members maintained a divergent opinion, citing a negative benefit-risk balance due to limited efficacy and substantial ARIA risks.
Key findings โ cited to the page
| Infusion-related reactions (IRR) | 8.7 % | ยท p.125 |
| Severe IRRs | 4.0 % | ยท p.125 |
| IRR severity: severe | 4% | ยท p.101 |
| Treatment discontinuations due to IRR | 3.6% | ยท p.101 |
| IRR severity: mild | 57% | ยท p.101 |
| IRR severity: moderate | 39% | ยท p.101 |
| IRR TEAEs severity: severe (All Dona) | 5.1% | ยท p.101 |
| IRR TEAEs severity: moderate (All Dona) | 38.4% | ยท p.101 |
| Serious hypersensitivity, anaphylactic, or IRR event (donanemab) | 0.4% | ยท p.101 |
| Serious hypersensitivity, anaphylactic, or IRR event (placebo) | 0.1% | ยท p.101 |
| Infusion-related reaction (IRR) incidence (donanemab) | 8.7% | AACI-PC ยท p.100 |
| IRR TEAEs severity: mild (All Dona) | 56.5% | ยท p.101 |
Source: Eli Lilly and Company โ ยท License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only โ not investment advice. Explore the Neurology library โ