Eisai Co., Ltd. — Leqembi FDA Review (BLA761269, ORIG 1, 2023)
Eisai Co., Ltd. · 2023 · FDA Review (openFDA) · company profile →
Report summary
This clinical review of Eisai's BLA 761269 for lecanemab (LEQEMBI) for early Alzheimer's disease, with a proposed dosing of 10 mg/kg biweekly, primarily focuses on safety data from Study 201 Core and its Open Label Extension. Key safety concerns include Amyloid-Related Imaging Abnormalities (ARIA-E and ARIA-H), which were more frequent in lecanemab-treated patients, especially ApoE ε4 carriers and females, and led to higher discontinuation rates. Other adverse events included infusion-related reactions, cardiac events (e.g., atrial fibrillation), and transient hematological changes. Two deaths potentially linked to cerebral hemorrhage were noted. Efficacy, based on amyloid plaque reduction and favorable trends in clinical endpoints, supports accelerated approval. Challenges included data integrity and underrepresentation of certain demographics. Recommendations for MRI monitoring and ARIA management are provided.
Key findings — cited to the page
| Grade 2 infusion related reactions (LEC10-BW) | 59 % | · p.145 |
| Infusion related reactions classified as grade 1 or 2 (proposed dose arm) | 76 % | · p.145 |
| Agitation incidence under FDA Irritability N MQG | 2 % | Placebo · p.73 |
| Grade 1 infusion related reactions (LEC10-BW) | 31 % | · p.145 |
| Grade 1 infusion related reactions (placebo) | 1.6 % | · p.145 |
| Grade 2 infusion related reactions (placebo) | 1.6 % | · p.145 |
| Suicidal ideation CSSR grade | 4.3 | 201 Core · p.193 |
| Agitation incidence under FDA Irritability N MQG | 3 % | LEC10-BW · p.73 |
| Irritability incidence under FDA Irritability N MQG | 2 % | LEC10-BW · p.73 |
| Irritability incidence under FDA Irritability N MQG | 0.8 % | Placebo · p.73 |
| Grade 3 infusion related reactions (LEC10-BW) | 6 % | · p.145 |
| Infusion related reactions classified as grade 1 or 2 (placebo arm) | 100 % | · p.145 |
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 →