Drug updated on 4/16/2024
| Dosage Form | Injection (intravenous; 500 mg/5 mL (100 mg/mL), 200 mg/2 mL (100 mg/mL) solution in single-dose vials) |
| Drug Class | Amyloid beta-directed antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of Alzheimer's disease.
Summary
- Leqembi (Lecanemab) is utilized for the management of Alzheimer's disease, targeting amyloid-beta plaques to slow disease progression and mitigate cognitive decline.
- Four studies were examined, focusing on the safety and overall effectiveness of anti-Aβ monoclonal antibodies, including Leqembi.
- The results indicate that Leqembi improves cognitive outcomes and biomarkers related to Alzheimer's pathology, though these effects are statistically significant but small in size.
- A major safety concern with Leqembi is an increased risk of Amyloid Related Imaging Abnormalities (ARIA), especially among APOE4 carriers, highlighting the importance of careful analysis when considering benefits versus potential adverse outcomes.
- In comparison with other treatments such as aducanumab, solanezumab, bapineuzumab, and angiotensin-receptor blockers (ARBs), Leqembi demonstrates potential in slowing cognitive decline for early-stage Alzheimer's patients, despite a higher risk for ARIA than observed with ARBs.
- Subgroup analyses based on genetic markers, like the presence of the APOE4 allele, are essential in evaluating risks versus benefits. This includes assessing changes in amyloid PET SUVr and amyloid burden on PET as critical metrics under Leqembi treatment.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Leqembi (lecanemab-irmb) Prescribing Information. | 2023 | Eisai Inc., Nutley, NJ |