Clinical TrialJul 14, 2026, 11:20 AM
Biogen: LEQEMBI LEADER Study Shows 82.5% Stability/Improvement
AI Summary
Eisai and Biogen announced positive real-world results from the LEADER Study for LEQEMBI in early Alzheimer's disease. The study showed that nearly 83% of patients (82.5%) remained stable or improved over an average of 17 months of treatment, with 75.9% stable and 6.6% improving. These outcomes were consistent across diverse patient demographics, and the safety profile aligned with the FDA-approved label, with no new severe ARIA events reported during maintenance therapy. The findings suggest long-term benefits and high treatment persistence for LEQEMBI.
Key Highlights
- 82.5% of early AD patients in LEADER Study remained stable or improved with LEQEMBI.
- 75.9% of patients remained stable, and 6.6% improved from mild AD dementia to MCI due to AD.
- Results were consistent across sex, race, ethnicity, and APOE genotype.
- Mean duration of LEQEMBI treatment was 520 days (approx. 17 months).
- Nearly 87% of patients chose to remain on LEQEMBI treatment.
- Overall safety observations, including ARIA incidence (12.3%), were consistent with the U.S. FDA-approved label.
- No new ARIA-E events, macrohemorrhages, or intracerebral hemorrhages >1 cm reported during IV maintenance therapy.
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