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Eisai Presents New Data on the Continued and Expanding Benefit of LEQEMBI® (Lecanemab-Irmb) Maintenance Treatment in Early Alzheimer's Disease at the Clinical Trials on Alzheimer's Disease (CTAD) Conference 2025

New data show lecanemab subcutaneous dosing matches IV efficacy, delays progression by up to 8.3 years, and reduces infusion reactions, Eisai and Biogen reported.

  • On Dec. 3, 2025, Eisai Co., Ltd. and Biogen Inc. presented CTAD data suggesting LEQEMBI may delay moderate Alzheimer's progression up to 8.3 years in a low-amyloid early-start group.
  • Using pooled Clarity AD open-label extension and 16 clinical studies of monoclonal antibodies for AD, analysts modeled long-term progression versus ADNI natural-history data using Clinical Dementia Rating- Sum of Boxes , indicating continued lecanemab may further delay decline.
  • Weekly 500 mg SC dosing showed prior-exposed patients had 0% systemic infusion reactions with 500 mg SC, 1.4% ADA incidence, and ARIA‑E incidence comparable to IV dosing in the Clarity AD subcohort.
  • Clinicians are advised to test ApoE status and perform baseline and periodic brain MRI, as ARIA‑E was observed in 3% versus 2% with placebo, with early-occurring radiographic ARIA‑E events.
  • Recent regulatory steps include U.S. regulatory filings for subcutaneous initiation and maintenance, a completed sBLA, and a Japan regulatory submission with LEQEMBI approvals in 51 countries and IV maintenance dosing authorizations.
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The Berkshire EagleThe Berkshire Eagle
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Eisai Presents New Data on the Continued and Expanding Benefit of LEQEMBI® (lecanemab-irmb) Maintenance Treatment in Early Alzheimer's Disease at the Clinical Trials on Alzheimer's Disease (CTAD) Conference 2025

Long-term LEQEMBI treatment suggests potential to delay disease progression from Mild Cognitive Impairment (MCI) to moderate Alzheimer's disease by up to 8.3 years in low-amyloid group who started treatment at an early stage

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pressreach.com broke the news in on Wednesday, December 3, 2025.
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