EISAI INC — Leqembi FDA Summary Review (NDA/BLA 761269, 2023)
Eisai Co., Ltd. · 2023 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
Lecanemab received accelerated FDA approval for Alzheimer's disease due to its significant reduction in amyloid plaque, addressing a critical unmet medical need. While demonstrating statistically significant plaque reduction, clinical efficacy interpretation was challenged by trial design and subgroup imbalances, especially in ApoE ε4 carriers. Safety concerns primarily involve Amyloid-Related Imaging Abnormalities (ARIA-E and ARIA-H), which were more frequent in ApoE ε4 carriers, and infusion-related reactions. The report details adverse events, including serious events and discontinuations, and outlines monitoring strategies and dosing recommendations to manage ARIA. No signals for suicidality, abuse potential, or carcinogenicity were found, though immunogenicity assay sensitivity was limited.
Key findings — cited to the page
| Irritability in lecanemab 10 mg/kg biweekly | 5 % | 201 Core · p.36 |
| Irritability in placebo | 2 % | 201 Core · p.36 |
| Pearson correlation coefficient between amyloid PET and ADAS-Cog14 | 0.699 | · p.27 |
| LS mean difference in total hippocampus volume (lecanemab 10 mg/kg biweekly vs placebo) | -19 mm3 | · p.26 |
| Pearson correlation coefficient between amyloid PET and ADCOMS | 0.832 | · p.27 |
| Pearson correlation coefficient between amyloid PET and CDR-SB | 0.805 | · p.27 |
| Change from baseline in brain amyloid plaque (Centiloids) | -73.5 Centiloids | · p.22 |
| Change from baseline in brain amyloid plaque (SUVR) | -0.310 | · p.22 |
| LS mean difference in plasma Aβ42/40 ratio (lecanemab 10 mg/kg biweekly vs placebo) | 0.0054 | · p.26 |
| LS mean difference in plasma p-tau 181 (lecanemab 10 mg/kg biweekly vs placebo) | -1.20 pg/ml | · p.26 |
| LS mean difference in total ventricular volume (lecanemab 10 mg/kg biweekly vs placebo) | 2318 mm3 | · p.27 |
| Probability of 10 mg/kg biweekly regimen being superior to placebo by 25% (ADCOMS) | 64 % | · p.25 |
Source: Eisai Co., Ltd. ↗ · 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 →