Eisai Co., Ltd. — Leqembi EMA EPAR public assessment report (EMEA/H/C/005966, 2025)
Eisai Co., Ltd. · 2025 · EMA EPAR public assessment report · company profile →
Report summary
The EMA assessed Leqembi (lecanemab) for mild Alzheimer's disease, ultimately recommending marketing authorization after an initial negative opinion. Leqembi, a humanized IgG1 monoclonal antibody targeting amyloid beta protofibrils, demonstrated statistically significant but clinically modest slowing of disease progression in the pivotal Phase 3 study (BAN2401-G000-301), particularly in APOE4 non-carriers and heterozygotes. Safety concerns, primarily Amyloid-Related Imaging Abnormalities (ARIA-E and ARIA-H), were significant, with higher incidence and severity in APOE4 homozygous carriers, leading to their exclusion from the recommended indication. Other adverse events included infusion-related reactions and intracerebral hemorrhages, some fatal. The CHMP's final recommendation includes extensive risk minimization measures, post-marketing studies, and a controlled access program, despite some members maintaining a negative benefit-risk assessment due to limited efficacy and substantial ARIA risks.
Key findings — cited to the page
| IRR frequency | 26 % | LEC10 BW · p.148 |
| ADCS-MCI-ADL function preserved (Overall Population) | 7.5 months | LEC10-BW · p.258 |
| Grade 1 infusion-related reactions in Pool LEC10 BW | 7.8 % | Pool LEC10 BW · p.123 |
| Grade 4 infusion-related reactions in Pool LEC10 BW | 0.1 % | Pool LEC10 BW · p.123 |
| ADAS-Cog14 cognition preserved (Overall Population) | 5.9 months | LEC10-BW · p.257 |
| ADAS-Cog14 cognition preserved (Noncarrier and Heterozygous APOE4 Carrier Population) | 6.4 months | LEC10-BW · p.257 |
| Grade 3 infusion-related reactions in LEC10-M | 1.6 % | Study 201 · p.123 |
| Grade 3 infusion-related reactions in LEC10-BW | 1.2 % | Study 201 · p.123 |
| Grade 2 infusion-related reactions in Pool LEC10 BW | 15.5 % | Pool LEC10 BW · p.123 |
| Grade 3 infusion-related reactions in Pool LEC10 BW | 0.6 % | Pool LEC10 BW · p.123 |
| CDR-SB time preserved (Noncarrier and Heterozygous APOE4 Carrier Population) | 6.1 months | LEC10-BW · p.256 |
| ADCS-MCI-ADL function preserved (Noncarrier and Heterozygous APOE4 Carrier Population) | 8 months | LEC10-BW · p.258 |
Source: Eisai Co., Ltd. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →