EISAI INC — Leqembi FDA Review (NDA/BLA 761269, 2024)
Eisai Co., Ltd. · 2024 · FDA Review (Drugs@FDA) · company profile →
Report summary
Eisai Inc.'s Leqembi (lecanemab-irmb) received FDA approval on July 6, 2023, for early Alzheimer's disease. This approval, following an accelerated approval in January 2023, was based on robust efficacy data from Study 301 (CLARITY-AD), demonstrating statistically significant reductions in clinical decline (CDR-SB, ADAS-Cog14) and amyloid beta plaque. However, the drug carries significant safety concerns, primarily Amyloid-Related Imaging Abnormalities (ARIA), including ARIA-E (edema) and ARIA-H (hemorrhage). These risks are notably higher in ApoE ε4 homozygotes and patients on antithrombotic medications. Postmarketing requirements include extensive safety monitoring, particularly for ARIA and intracerebral hemorrhage in specific subpopulations. The prescribing information details dosage, administration, contraindications, and common adverse reactions like infusion-related reactions and headache. The FDA also mandated further studies to assess ARIA risks in specific subgroups.
Key findings — cited to the page
| PMR 4497-1 Study Completion | 01/2035 | Leqembi · p.6 |
| PMR 4497-3 Final Report Submission | 02/2030 | Leqembi · p.7 |
| PMR 4497-1 Interim Study Report Submissions end | 10/2034 | Leqembi · p.6 |
| ApoE ε4 noncarriers (301 Core) | 31 % | Study 301 Core · p.78 |
| Indication | treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. | Leqembi · p.1 |
| BLA Supplement Approval letter date | July 6, 2023 | Leqembi · p.4 |
| sBLA submission date | January 6, 2023 | Leqembi · p.4 |
| Approval Date | July 6, 2023 | Leqembi · p.1 |
| PMR 4497-1 Draft Protocol Submission | 03/2024 | Leqembi · p.5 |
| PMR 4497-1 Final Protocol Submission | 01/2025 | Leqembi · p.5 |
| PMR 4497-1 Interim Study Report Submissions start | 10/2025 | Leqembi · p.5 |
| PMR 4497-1 Final Report Submission | 01/2036 | Leqembi · p.6 |
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 →