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LEQEMBI(R) Real-World LEADER Study Presented at AAIC(R) 2026 Finds Over 75% of Early Alzheimer’s Patients Enrolled in the Study Remained Stable and Nearly 7% Improved Over approximately 17 Months of Treatment

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TOKYO and CAMBRIDGE, Mass., July 15, 2026 – (JCN Newswire) – Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) revealed today that arises from the real-world Lecanemab in Early Alzheimer’s Disease (LEADER) Study reveal that almost 83% of early Alzheimer’s illness (ADVERTISEMENT) clients registered in the research study stayed steady (75.9%) or enhanced (6.6%) while getting LEQEMBI ® treatment over approximately 17 months. The outcomes corresponded throughout sex, race, ethnic background and APOE genotype. The information existed throughout the “Developing Topics Session # 3-33-DEV-A: Lecanemab Three Years Post-Approval: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER) in Diverse United States Clinical Settings” at the Alzheimer’s Association International Conference ®( AAIC ® )2026 in London and online.

Advertisement is a persistent, progressive illness that needs continuous treatment. LEQEMBI targets the underlying pathology of the illness and operates in 2 methods throughout treatment – by eliminating insoluble (plaque) and soluble amyloid beta (protofibrils), assisting to slow cognitive decrease and loss of day-to-day performance. Information reveal ongoing treatment with LEQEMBI might have the ability to assist keep clients in early advertisement for longer. Early advertisement consists of moderate cognitive disability (MCI) due to advertisement and moderate advertisement dementia.

LEADER Study Design

The three-year LEADER Study is a multicenter, retrospective real-world research study created to analyze LEQEMBI usage, treatment determination, shift to upkeep treatment, security, cognitive and practical evaluations, and health care expert (HCP) application knowings in varied U.S. medical settings for clients with early Alzheimer’s illness (ADVERTISEMENT). The research study incorporated deidentified chart and electronic medical record (EMR) information from 13 U.S. websites, HCP studies and HCP interviews. This interim analysis consisted of 432 clients with early advertisement who got a minimum of 7 LEQEMBI infusions since May 2026.

Client Characteristics at Baseline
* Mean age: 74 years
* Female Patients: 55.8%

Illness Stage at Baseline
* Mild cognitive disability (MCI) due to advertisement: 63.9%
* Mild advertisement dementia: 36.1%.

Treatment
* The mean period of LEQEMBI treatment was 520 days. – The mean variety of LEQEMBI dosages was 26.
* Change in illness phase was specified as:
– Stable – Patient staying in the very same illness phase (MCI due to advertisement or moderate advertisement dementia)from standard throughout the course of LEQEMBI treatment.
– Improvement – Patient transitioning from moderate advertisement dementia at standard to MCI due to advertisement overthe course of LEQEMBI treatment.
– Progression – Patient advancing from MCI at standard to mild/moderate advertisement dementia or from moderate advertisement dementia at standard to moderate advertisement dementia throughout the course of LEQEMBI treatment.

LEADER Study Key Findings

Real-World Evidence Shows Long-Term Benefit with Continuous LEQEMBI Treatment Across Sex, Race, Ethnicity and APOE Genotype

General Study Population Findings
* Of the 432 individuals registered in the LEADER research study, illness phase might be assessed in 427. Amongst these clients with early Alzheimer’s illness, 82.5% stayed steady or enhanced while getting LEQEMBI, with constant outcomes throughout sex, race, ethnic culture, and APOE genotypegroups.
* 75.9% stayed steady compared to standard, indicating they stayed in the exact same illness stagethroughout treatment.
* 6.6% enhanced from standard, moving from moderate advertisement dementia to MCI due to advertisement.
* Nearly 87% of clients selected to stay on LEQEMBI treatment.
* In analyses by APOE ε4 status, clinician-evaluated steady or better illness phase was observed in:
– 81.7% of APOE ε4 heterozygotes (steady: 73.8.%; enhanced: 7.9%)
– 81.0% of APOE ε4 homozygotes (steady: 75.9%; enhanced: 5.2%).

Upkeep Dosing Population Findings
– Of the 432 individuals in the LEADER research study, 155 transitioned to once-every-four-weeks intravenous(IV) upkeep treatment, and 14 transitioned to once-weekly subcutaneous (SC) upkeep treatment.
– Among the 155 individuals who transitioned to IV upkeep treatment, almost 81% stayed steady(72.3%) or enhanced (8.4%).
– Of the 14 clients who transitioned to SC upkeep treatment, 12 (85.7%) preserved their illness phase.

Real-World Safety Consistent with U.S. FDA-Approved Label

General security observations in this real-world research study followed the U.S. FDA-approved label.
– ARIA (amyloid-related imaging problems)* was observed in 12.3% of clients in general; ARIA-E was observed in 6.3% and ARIA-H in 7.9% and separated ARIA-H in 6.0%. The majority of ARIA cases were asymptomatic and moderate in radiographic intensity.
– No brand-new ARIA-E occasions, macrohemorrhages or intracerebral hemorrhages higher than 1 cm were reported throughout once-every-four-weeks IV upkeep treatment.

APOE ε4 status security observations followed the general friend and the U.S. FDA-approved label.
– ARIA-E was observed in 5.3% of APOE ε4 noncarriers, 6.1% of APOE ε4 heterozygotes and 10.3%of APOE ε4 homozygotes.
– ARIA-H was observed in 12.1%, 4.8% and 12.1%, respectively.
– In APOE ε4 homozygotes, no extreme ARIA was reported, and all graded ARIA cases were moderate to moderate in radiographic intensity.

Antithrombotic treatment, consisting of anticoagulants or antiplatelet medications, was utilized by 106 clients, representing 24.5% of the research study population.
– Of these, 11 clients were getting an anticoagulant, either alone or with an antiplatelet medication, and 95 clients were getting antiplatelet treatment just.
– Among clients getting antithrombotic treatment, the occurrence of ARIA was not meaningfully various from that observed in clients not getting antithrombotic treatment.

* ARIA describes amyloid-related imaging problems that can be observed with anti-amyloid beta antibody treatment and consists of ARIA-E, which includes edema/effusion, and ARIA-H, which includes hemosiderin deposition, consisting of cerebral microhemorrhage, cerebral macrohemorrhage and shallow siderosis, as observed on brain magnetic resonance imaging (MRI).

Eisai functions as the lead for lecanemab’s advancement and regulative submissions worldwide with Eisai and Biogen co-commercializing and co-promoting the item and Eisai having last decision-making authority.

MEDIA CONTACTS
Eisai Co., Ltd.
Public Relations Department
TEL: +81 (0 )3-3817-5120

Eisai Europe, Ltd.
EMEA Communications Department
+44 (0 )7760 619251
Emea-comms@eisai.net

Eisai Inc. (U.S.)
Julie Edelman
+1 -862 -213 -5915
Julie_Edelman@eisai.com

Biogen Inc.
Madeleine Shin
+1 -781 -464 -3260
public.affairs@biogen.com

FINANCIER CONTACTS

Eisai Co., Ltd.
Financier Relations Department
TEL: +81 (0) 3-3817-5122

Biogen Inc.
Tim Power
+ 1-781-464-2442
IR@biogen.com

For more details: https://www.eisai.com/news/2026/pdf/enews202641pdf.pdf


Subject: Press release summary

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