Eli Lilly and Company — Kisunla FDA Review (BLA761248, ORIG 1, 2024)
Eli Lilly and Company · 2024 · FDA Review (openFDA) · company profile →
Report summary
Eli Lilly's Biologics License Application for Kisunla (donanemab) for Alzheimer's disease seeks traditional approval after a previous Complete Response letter. Clinical trials (AACI, AACG) demonstrated statistically significant and clinically meaningful benefits in cognition and function, with a 20-30% reduction in decline, and significant amyloid plaque reduction. Safety analyses, encompassing multiple studies, revealed common adverse events including Amyloid-Related Imaging Abnormalities (ARIA-E: 27% vs. 1% placebo; ARIA-H microhemorrhage: 20% vs. 5% placebo), leading to a 31% discontinuation rate in the donanemab arm of Study AACG. Other serious adverse events included intracerebral hemorrhage, hypersensitivity, and infusion-related reactions. While no deaths were directly attributed to donanemab, several fatalities occurred, some with potential links to ARIA. The safety database met ICH guidelines for exposure, but long-term safety characterization remains limited. An advisory committee unanimously supported donanemab's effectiveness and favorable benefit-risk profile, recommending a boxed warning for ARIA-related deaths.
Key findings — cited to the page
| Irritability Fda N MQG | 1 % | all-donanemab pool · p.524 |
| Irritability Fda N MQG | 2 n | all-donanemab pool · p.524 |
| Hypersensitivity/IRR events within 24 hours occurring during/within 30 mins of infusion (all-donanemab pool) | 83 % | · p.542 |
| Hypersensitivity/IRR events within 24 hours occurring during/within 30 mins of infusion (donanemab-treated) | 84 % | Study AACG · p.542 |
| Participants reporting at least one hypersensitivity/IRR event within 24 hours of infusion | 3 % | Study AACG · p.543 |
| Hypersensitivity/IRR events during drug administration (donanemab) | 12 % | Study AACG · p.543 |
| Sodium shift to Grade 3 (Placebo) | 0 % | · p.150 |
| Sodium shift to Grade 2 (Placebo) | 0.6 % | · p.150 |
| Sodium shift to Grade 2 (Donanemab) | 1.2 % | · p.150 |
| Sodium shift to Grade 3 (Donanemab) | 0.2 % | · p.150 |
| Participants reporting at least one hypersensitivity/IRR event within 24 hours of infusion | 14 % | Study AACG · p.543 |
| Hypersensitivity/IRR events during drug administration (placebo) | 2 % | Study AACG · p.543 |
Source: Eli Lilly and Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →