Leqembi (lecanemab-irmb) / Biogen, BioArctic, Eisai - LARVOL DELTA

Time-saved and time-invested with anti-amyloid treatments in early Alzheimer's disease: practical considerations. (PubMed, J Clin Neurosci) - "In this study, we report that nearly half of the possible eligible patients for anti-amyloid treatments experience a reduction in motivation after receiving the information about the number of times required to come to the hospital, especially those travelling long distances (average time: 60 min for one-way). We propose a rough estimate for the additional time patients and their family members are likely to spend in these arrangements and suggest these additional calculations should be part of the decision-making process."

Journal • Alzheimer's Disease • CNS Disorders

Racial and ethnic differences in plasma p-tau217 ratio biomarker eligibility rates in a preclinical AD trial with lecanemab. (PubMed, Alzheimers Dement (Amst)) - "Differential rates of plasma eligibility, but consistent PET eligibility among plasma-eligible participants, were observed, supporting the use of universal biomarker cutpoints across race and ethnic groups.Highlights: Underrepresented racial and ethnic groups had lower rates of plasma eligibility compared to non-Hispanic White individuals based on a plasma screening algorithm that included the phosphorylated tau 217 ratio.Among plasma-eligible participants, amyloid positron emission tomography eligibility rates did not differ by racial and ethnic group.Plasma biomarker tests may provide equivalent effectiveness for identifying imaging biomarker eligible, cognitively unimpaired individuals across racial and ethnic groups."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • APOE • Aβ42

Causal effect of conventional anti-dementia drugs on economic burden: an orthogonal double/debiased machine learning approach. (PubMed, BMC Geriatr) - "This study revealed the causal relationship between anti-dementia drug use and Medicare costs by employing DML. ChEIs were found to be contributors to the decreased Medicare costs and inpatient costs, which could mainly be attributed to donepezil. The use of donepezil should be expanded, considering the significant benefits. Furthermore, a lower OOP cap for ADRD beneficiaries should be established under the IRA."

HEOR • Journal • Alzheimer's Disease • CNS Disorders • Dementia

Eisai Co., Ltd…and Biogen Inc…announced…that the anti-amyloid beta (Aβ) monoclonal antibody “LEQEMBI” has been launched in Austria on August 25, 2025 and will be launched in Germany on September 1, 2025. (Eisai Press Release) - "Germany and Austria will mark the first launches in the EU."

Launch Europe • Alzheimer's Disease

New Data Presented at AAIC Demonstrates Investigational LEQEMBI (lecanemab-irmb) 360 mg Subcutaneous Maintenance Dosing Could Offer a New Option for Ongoing Treatment of Early Alzheimer’s Disease (Eisai Press Release) - P3 | N=1,906 | Clarity AD (NCT03887455) | Sponsor: Eisai Inc. | "The safety profile of 360 mg weekly SC maintenance dosing was shown to be consistent with that of IV maintenance therapy, with <1% systemic injection/infusion reactions....The HF Study involved 110 participants (63 early AD patients, 32 care partners, and 15 healthcare professionals: HCPs) to assess the appropriate administration of lecanemab SC-AI. Overall, 95% (104/110) of participants successfully administered the maintenance dose. The Autoinjector Device Acceptability Study involved 126 participants (25 early AD patients, 50 care partners, and 51 HCPs), to evaluate the device's ease of use, convenience and feasibility of administration. As an interim outcome, over 95% of participants reported that the SC-AI is easy to administer. They were highly satisfied with it and had no concerns about administration, even at home. Furthermore, all patients responded that they welcomed the introduction of SC-AI."

P3 data • Alzheimer's Disease

What to know about 2 new Alzheimer’s disease drugs approved in Singapore (Straits Times) - "Tackling Alzheimer’s disease in Singapore received a boost earlier in 2025, when the authorities approved two new drugs for the neurodegenerative disease. Although these drugs - lecanemab and donanemab - cannot cure or reverse the effects of Alzheimer’s, they have been shown to slow the progression of the disease, which accounts for almost 70 per cent of dementia cases worldwide....Findings from the clinical trial of lecanemab, published in the New England Journal of Medicine, showed that it slowed decline for people with early Alzheimer’s disease by about 27 per cent to 37 per cent. Meanwhile, results from donanemab’s Phase 3 clinical trial, published in the Journal of the American Medical Association, showed that the drug slowed cognitive decline by about 20 per cent to 29 per cent."

Approval • Alzheimer's Disease

A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P2 | N=105 | Active, not recruiting | Sponsor: Eisai Inc. | Trial completion date: Aug 2027 ➔ Feb 2027 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Biomarker • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

The structural foundations of anti-amyloid-β immunotherapies: Unravelling antibody-antigen interactions in Alzheimer's disease treatment. (PubMed, J Alzheimers Dis) - "BackgroundAnti-amyloid-β (Aβ) immunotherapies are emerging as treatments for Alzheimer's disease (AD).ObjectiveThis review examines the structure-activity relationships of anti-Aβ therapeutics tested in phase 3 trials.MethodsWe analyzed crystallographic data and molecular models to elucidate the Aβ binding mechanisms of donanemab, lecanemab, aducanumab, bapineuzumab, gantenerumab, solanezumab, and crenezumab.ResultsLecanemab recognizes minimally degraded Aβ missing 1-2 residues, avoiding common Aβ in circulation and further degraded material sequestered in plaques. This focal point may account for the significant cognitive effects of lecanemab. The structure of aducanumab suggests a broadly neutralizing role has evolved for natural immunity to AD."

Journal • Review • Alzheimer's Disease • CNS Disorders • Vascular Neurology • APOE

Early Alzheimer's Patients Continue to Benefit from Four Years of LEQEMBI (lecanemab-irmb) Therapy New Clinical Data Presented at AAIC (PRNewswire) - P3 | N=1,906 | Clarity AD (NCT03887455) | Sponsor: Eisai Inc. | "Clarity AD is a global Phase 3 placebo-controlled, double-blind, parallel-group, randomized study to evaluate lecanemab 10 mg/kg bi-weekly IV treatment of early Alzheimer's disease, which involved 1,795 patients (treatment group: 898, placebo group: 897)...In the Clarity AD core study, the mean change from baseline between the lecanemab treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale...Over three years of treatment, including both the core study and the OLE, data showed lecanemab demonstrated a reduction in cognitive decline—measured by CDR-SB—of 1.01 points compared to the expected decline observed in the Alzheimer's Disease Neuroimaging Initiative (ADNI) cohort....Among these patients, after four years of lecanemab treatment, 69% of these patients showed improvement..."

P3 data • Alzheimer's Disease

EISAI TO PRESENT FOUR-YEAR EFFICACY AND SAFETY DATA ON CONTINUOUS TREATMENT WITH LECANEMAB AT THE ALZHEIMER'S ASSOCIATION INTERNATIONAL CONFERENCE 2025 (PRNewswire) - "Key Oral Lecanemab Presentations: (i) Four-year Data: On Wednesday, July 30...initial four-year findings will be presented on lecanemab from the Phase 3 Clarity AD Open-Label Extension in Early Alzheimer's Disease trial; (ii) Subcutaneous Maintenance Dosing: A Featured Research Session on Wednesday, July 30 (9:00 - 10:30 AM EDT) will include data on the potential of a new and convenient option for ongoing lecanemab treatment...; (iii) Real World Case Studies: A Developing Topics Session on Sunday, July 27 (9:00 – 10:30 AM EDT) will include data on real-world case studies and patient pathway learnings from diverse U.S. clinical settings two years post-approval of lecanemab. Key Lecanemab Poster Presentation: (i) A Poster Presentation on Monday, July 28...will share findings on cerebrospinal fluid (CSF) samples collected from the Clarity AD trial and analyzed using the novel, sensitive immunoassay developed to measure Aβ protofibrils in CSF."

Clinical data • Real-world • Alzheimer's Disease

The Clinical Study of Synaptic Plasticity-based Lencanumab for the Treatment of Early Alzheimer's Disease (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: Cuibai Wei，Clinical Professor | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

Amyloid Clearance and Transient CSF Aβ40 Reduction in a Case of ARIA-E/H Following Lecanemab Treatment. (PubMed, Intern Med) - "CSF Aβ40 levels transiently decreased by ~30% during the ARIA episode, whereas Aβ42 remained stable, thereby increasing the Aβ42/40 ratio. These findings suggest that ARIA may facilitate focal amyloid clearance and that CSF Aβ40 reduction may serve as a potential biomarker for ARIA onset and resolution."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Epilepsy • Aβ42 • CSF Aβ40

Food And Drug Authority Approves First Alzheimer’s Treatment Called Leqembi In Saudi Arabia (Forbes) - "The Saudi Food and Drug Authority (SFDA) has approved leqembi, also known as lecanemab, as the first treatment for Alzheimer’s disease in Saudi Arabia...The approval covers patients with mild cognitive impairment or mild dementia caused by Alzheimer’s who carry no copies or only one copy of the apolipoprotein E4 (ApoE4) gene variant, state-owned Saudi Press Agency (SPA) reported on Tuesday...The SFDA said it approved lecanemab after reviewing its safety, quality, and effectiveness. Clinical trials showed the drug slowed disease progression compared to a placebo, based on standard Alzheimer’s treatment measures."

Approval • Alzheimer's Disease • Dementia

Reducing ARIA risk in Alzheimer's disease: Real-world impact of APOE genotype-guided slow titration with aducanumab and lecanemab. (PubMed, J Alzheimers Dis) - "Plaque clearance was achieved in 50% of evaluable aducanumab patients and 26.3% of lecanemab patients. Compared to clinical trial ARIA rates, our results suggest that individualized, genotype-informed titration improves safety although plaque clearance rates were less robust."

Journal • Real-world evidence • Alzheimer's Disease • CNS Disorders • APOE

Probable lecanemab-associated pontine hemorrhage following cardiovascular intervention: Clinical implications for lecanemab use. (PubMed, J Alzheimers Dis Rep) - "She was initially on clopidogrel and rivaroxaban; rivaroxaban was discontinued prior to lecanemab initiation. Pontine hemorrhage occurred after twenty days. This case highlights heightened bleeding risk when lecanemab is combined with intensified antithrombotic therapy, even without APOE ε4 or significant cerebral small vessel disease load."

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Hematological Disorders • APOE

EEG-Based Efficacy Evaluation of Lecanemab Treatment in Alzheimer's Disease (ChiCTR) - P=N/A | N=20 | Not yet recruiting | Sponsor: Shenzhen people's hospital; Shenzhen people's hospital

New trial • Alzheimer's Disease • CNS Disorders

Evaluation of Amyloid Removal as a Surrogate for Cognitive Decline: Pilot Analysis in Individual-Level Data from the A4 Study of Solanezumab. (PubMed, medRxiv) - "Amyloid removal has been used as a surrogate outcome in Alzheimer's disease trials, allowing accelerated approval of aducanumab and lecanemab. Estimates showing near-zero effects of amyloid reduction on cognitive decline suggest minimal impact of amyloid reduction in populations with little disease progression. Replication in anti-amyloid trials with larger treatment effects could guide treatment and regulatory decisions."

Journal • Alzheimer's Disease • CNS Disorders

"Safety and Efficacy of Lecanemab in Alzheimer's Disease Patients with Post-Stroke Cognitive Impairment" (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Zhejiang Provincial People's Hospital; Zhejiang Provincial People's Hospital

New trial • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders

Alzheimer's Disease: Treatment Challenges for the Future. (PubMed, J Neurochem) - "These antibodies, lecanemab and donanemab, mark a turning point for our understanding of the disease pathogenesis and for the treatment of this prevalent disorder. This review discusses what they imply for disease pathogenesis and what is needed to progress from the current imperfect therapies toward safe and better, disease halting therapies. The research over the next period will involve drug development, largely aimed at reducing the side effects of the anti-amyloid therapies, biomarker and genetic research to try and identify patients earlier in the disease process, and neuropathological research in individuals who have received treatment to try and understand the pathological substrates of the continuing clinical decline in the disease."

Journal • Review • Alzheimer's Disease • CNS Disorders

Taiwan NHI excludes coverage for new Alzheimer's drug Kisunla (Focus Taiwan) - "Taipei, July 31 (CNA) Kisunla, a newly approved Alzheimer's drug in Taiwan, will not be covered by the National Health Insurance (NHI) system, while coverage for Leqembi, another Alzheimer's treatment approved this year, is still under review, a health official overseeing the NHI system said Thursday...Kisunla has already been reviewed by an expert panel, which concluded that although the drug has completed Phase 3 clinical trials, the follow-up period for users was too short and its long-term benefits remain unclear, National Health Insurance Administration (NHIA) Director-General Shih Chung-liang...said in a legislative session."

Reimbursement • Alzheimer's Disease

How many sites are enough? a novel, site-based power analysis method for real-world registry studies of anti-amyloid monoclonal antibodies. (PubMed, JAR Life) - "Simulated ALZ-NET and AD-DMT registry settings using prevalence and ARIA frequencies from published lecanemab and donanemab trials. Conventional methods risk underestimating site requirements by ignoring caseload heterogeneity. Our simulation framework provides more realistic estimates and, crucially, quantifies the substantial efficiency gains from strategic recruitment, serving as a flexible tool to optimize registry design."

Journal • Real-world evidence • APOE

Japan OKs Price Cut for Alzheimer's Drug Lecanemab (Nippon.com) - "A Japanese health ministry panel Wednesday approved a plan to cut the price of Lecanemab, an Alzheimer's drug codeveloped by Japanese drugmaker Eisai Co. and U.S. industry peer Biogen Inc., by 15 pct in Japan starting Nov. 1...The decision is based on an assessment by the Central Social Insurance Medical Council that cited the low cost-effectiveness of the drug used to treat dementia caused by Alzheimer's disease...The price of the drug will be lowered to 97,277 yen for a 500-milligram bottle. Dosages are based on weight. For example, a patient weighing 50 kilograms would see an annual cost reduction from about 2.98 million yen to about 2.53 million yen....The medication was subject to a system that adjusts drug prices based on cost-effectiveness for high-priced or large-market drugs."

Reimbursement • Alzheimer's Disease

Lecanemab (▼Leqembi) for Alzheimer's disease. (PubMed, Drug Ther Bull) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders • Dementia

Biogen raises sales outlook as Leqembi awaits FDA decision on new dosing option (Fierce Pharma) - "With 7% year-over-year sales growth in the second quarter to $2.6 billion, the company is slowly picking up after years of sales declines. The quarterly haul beat estimates from William Blair analysts, who expected $2.35 billion, along with the consensus forecast of $2.32 billion. Eisai-partnered Leqembi—the star of Biogen’s commercial profile—brought in about $160 million. While the Alzheimer’s disease drug generated $63 million in the U.S., analysts wrote in a client note that it has seen only “modest growth relative to expectations."

Sales • Alzheimer's Disease

Revenue of LEQEMBI (Preliminary Basis) (Eisai Press Release) - "Eisai Co., Ltd...announced today that the global revenue (pre-audit basis) of the anti-amyloid-beta protofibril antibody 'LEQEMBI' (generic name: lecanemab) was JPY 23.1 billion for the first quarter of fiscal year 2025 (April 1, 2025 – June 30, 2025). By major markets, revenue came to JPY 9.1 billion in the United States, JPY 5.5 billion in Japan, and JPY 7.7 billion in China due to increasing demand and stockpiling by distributors (estimated at JPY 5.3 billion) in response to the risk of tariffs."

Sales • Alzheimer's Disease