Kisunla(donanemab)
Neurology· 5530 cited findings· 2 source documents
Company: Eli Lilly and Company →
What the regulatory reviews say
Kisunla (donanemab) is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild AD dementia due to Alzheimer’s disease (Early symptomatic Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) non-carriers with confirmed amyloid pathology. The proposed dosing regimen is 700 mg IV every 4 weeks for the first 3 doses, followed by 1400 mg IV every 4 weeks.
In efficacy trials, donanemab demonstrated a 32% slowing of iADRS progression compared to placebo. The iADRS mean progression level for donanemab was -6.86 points, while for placebo it was -10.06 points. The CDR-SB LS mean Change Difference versus placebo was -0.56. The ADAS-Cog13 LS mean Change Difference versus placebo was -1.25.
Safety findings include an ARIA-E incidence of 24.0% and an ARIA-H incidence of 31.4%. There were 2 ARIA SAEs reported. The BLA submission date was May 18, 2022, with a Complete Response Letter issued on January 18, 2022. The EMA application was submitted on 24 July 2023, receiving a CHMP negative opinion on 27 March 2025, followed by a re-examination request on 10 April 2025, and a CHMP final opinion on 24 July 2025.
Key figures — cited to the source page
| iADRS slowing (donanemab vs placebo) | 32 | Eli Lilly and Company — Kisunla EMA EPAR public assessment r, p.58 |
| iADRS mean progression level (donanemab) | -6.86 | Eli Lilly and Company — Kisunla EMA EPAR public assessment r, p.58 |
| iADRS mean progression level (placebo) | -10.06 | Eli Lilly and Company — Kisunla EMA EPAR public assessment r, p.58 |
| CDR-SB LS mean Change Difference versus placebo | -0.56 | Eli Lilly and Company — Kisunla EMA EPAR public assessment r, p.67 |
| ADAS-Cog13 LS mean Change Difference versus placebo | -1.25 | Eli Lilly and Company — Kisunla EMA EPAR public assessment r, p.67 |
| ARIA-E incidence | 24.0 | Eli Lilly and Company — Kisunla EMA EPAR public assessment r, p.124 |
| ARIA-H incidence | 31.4 | Eli Lilly and Company — Kisunla EMA EPAR public assessment r, p.124 |
| CHMP final opinion date (re-examination) | 24 July 2025 | Eli Lilly and Company — Kisunla EMA EPAR public assessment r, p.10 |
Source documents
Compared with
Explore the full evidence
All 5530 cited findings for Kisunla — searchable, comparable and answerable in plain language — are in the Neurology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.