Clinical TrialJul 12, 2026, 11:19 AM
Biogen: LEQEMBI SC-AI Shows Comparable Efficacy to IV for Alzheimer's
AI Summary
Eisai Co., Ltd. and Biogen Inc. announced new data at AAIC 2026, demonstrating that the LEQEMBI (lecanemab) subcutaneous autoinjector (SC-AI) formulation offers comparable efficacy and safety to intravenous (IV) administration for people with early Alzheimer’s disease. The data showed that once-weekly 500 mg SC-AI achieved drug exposure similar to the approved IV regimen, supporting similar clinical efficacy and safety. This subcutaneous option provides a convenient at-home alternative, potentially improving access and long-term disease management, with high patient and care partner satisfaction.
Key Highlights
- LEQEMBI SC-AI achieved drug exposure similar to IV administration for early Alzheimer's.
- Once-weekly 500 mg SC-AI showed bioequivalence to IV (10 mg/kg every two weeks) with 104% exposure ratio.
- Efficacy and safety were driven by drug exposure, not the route of administration.
- Consistent results for exposure, amyloid clearance, efficacy, and safety across body weight groups.
- Patients can flexibly switch between IV and SC administration of LEQEMBI.
- Overall safety profile of SC-AI was consistent with the IV formulation.
- Patient and care partner satisfaction with SC LEQEMBI ranged from 75% to 97%.
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