Latest news with #lecanemab
Medscape
06-08-2025
- Health
- Medscape
Lecanemab Preserves Memory Over 4 Years in Early AD
Continuous treatment with lecanemab (Leqembi, Eisai/Biogen) demonstrated sustained disease-modifying benefit over 4 years in patients with early-stage Alzheimer's disease (AD) enrolled in the open-label extension of the phase 3 CLARITY AD trial. Through 4 years, lecanemab 'meaningfully' delayed progression to dementia stage of disease compared to untreated observational cohorts, said study investigator Christopher van Dyck, MD, Yale University School of Medicine, New Haven, Connecticut. With 4 years of treatment, 'there is in the vicinity of a full year's time saved' in early-stage disease. In addition, more than half of patients in the low tau subgroup showed improvement in cognitive function over time, van Dyck added. The results were presented on July 30 at the Alzheimer's Association International Conference (AAIC) 2025. Widening Benefit Over Time The core CLARITY AD trial included 1795 adults with mild cognitive impairment or early AD and confirmed amyloid pathology in the brain. Treatment consisted of IV infusions of lecanemab 10 mg/kg biweekly (n = 898) or matching placebo (n = 897). After 18 months of treatment, lecanemab slowed cognitive and functional decline, as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB), by 27% compared with placebo — an absolute difference of 0.45 points ( P = .00005). To provide context, a change from 0.5 to 1.0 on the CDR score domains of memory, community affairs, and home/hobbies reflects a shift from mild impairment to loss of independence. Of the patients who completed the core 18-month study, 95% elected to continue in the open-label extension study, with 478 patients treated for 4 years. Some of these participants transitioned to once-monthly intravenous (IV) infusions, consistent with the FDA-approved regimen, and some transitioned to subcutaneous injections, a regimen currently under review by the FDA. Over 3 years of treatment, including both the core study and the open-label extension, lecanemab demonstrated a reduction in cognitive decline of 1.01 points on the CDR-SB compared to the expected decline observed in the Alzheimer's Disease Neuroimaging Initiative (ADNI) cohort, van Dyke reported. This benefit grew more pronounced after 4 years, with a reduction of 1.75 points compared to natural history. Similarly, when benchmarked against the expected decline in the BioFINDER cohort, lecanemab showed a reduction of 1.40 points at 3 years and 2.17 points at 4 years. Through 4 years, lecanemab reduced the relative risk of progression to next disease stage by 34% compared with ADNI; 53% of lecanemab-treated patients progressed to next disease stage vs 70% of those in the ADNI cohort. Lecanemab also reduced the relative risk of progression to dementia stage by 56%; 19% of lecanemab-treated patients progressed to dementia vs 37% of ADNI patients. Earlier Treatment Better Among participants in the tau PET substudy who had low tau levels, 69% showed improvement or no decline and 56% showed improvement from baseline on the CDR-SB after 4 years of lecanemab. Similar results were seen on the AD Assessment Scale-cognitive subscale-14; 51% of patients showed improvement or no decline, and 51% showed improvement. Likewise, on the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment, 64% of patients showed improvement or no decline, and 58% showed improvement. These findings suggest that starting and maintaining treatment with lecanemab in early-stage AD may help slow clinical decline and may provide sustained benefits over the long term, van Dyck said. No new safety signals were observed in the open-label extension phase with continued lecanemab treatment over 4 years. 'Most all of the adverse events actually go down in frequency over time, and none of them go up,' he said. Rates of amyloid-related imaging abnormalities (ARIA) decreased after the initial 12 months and remained consistent throughout four years of continuous treatment. Rates of ARIA related to edema (ARIA-E) were 13% at less than 12 months and declined to 1% at 36-48 months. Rates of ARIA related to hemorrhage (ARIA-H) were 15% at less than 12 months and 9% at 36-48 months. 'Exciting' Long-Term Data Reached for comment, Rebecca M. Edelmayer, PhD, vice president of scientific engagement for the Alzheimer's Association, told Medscape Medical News it's 'exciting to see that patients continue to show less decline and potentially even improvement in their clinical scores over time' and that the safety profile is 'consistent over time without any new types of safety events.' Edelmayer also noted that the open-label extension data from CLARITY-AD are in line with other 'real-world' data presented at AAIC 2025 from clinics using lecanemab that have demonstrated 'fairly similar safety and efficacy patterns.' Also providing perspective, Howard Fillit, MD, co-founder and chief science officer of the Alzheimer's Drug Discovery Foundation, noted that the analysis didn't have a stable control group, so the comparisons lean on historical data. But the fact that some patients improved or remained stable over time with continued lecanemab dosing is a 'major advance.' 'It's actually pretty amazing because not only has this historically been thought of as a chronic, uniformly progressive and ultimately fatal disease, but we never really thought that there would be a drug, at least I didn't, that would actually improve patients on a disease-modifying basis as this drug seems to do,' Fillit, who wasn't involved in the study, told Medscape Medical News . Fillit noted that the risk-benefit profile for lecanemab in this open-label study is 'fairly favorable. The rate of serious side effects is quite low, and I think this kind of study can help allay some of those fears about side effects.' He also noted that having a subcutaneous dosing option or lecanemab (if approved) will be a 'game changer' enabling at-home dosing and reducing the burden and inconvenience of having to go to a center to get an infusion of lecanemab. The FDA is set to decide on whether or not to approve the company's biologics license application for lecanemab subcutaneous autoinjector later this month.
The Independent
01-08-2025
- Health
- The Independent
Alzheimer's breakthrough as drug shown to delay progression by years
A new study indicates that the Alzheimer 's drug lecanemab can delay the progression of the disease by up to four years. Patients in the earliest stages of Alzheimer's who received lecanemab showed improvement or no decline in cognitive function over a four-year trial period. The drug demonstrated particular promise for individuals with low levels of tau protein, with 69 per cent of this subgroup showing no decline and 56 per cent improving cognitively. Lecanemab, a disease-modifying drug targeting amyloid protein, was approved for use in the UK last year due to its effectiveness in slowing disease progression. Despite its approval, lecanemab, along with similar drugs like donanemab, was rejected for NHS use in the UK, as the benefits were deemed too small to justify the cost.
Telegraph
31-07-2025
- Health
- Telegraph
Alzheimer's wonder drug delays disease for four years
Alzheimer's patients can stave off the progression of disease for four years with radical new treatments, The Telegraph can reveal. Trial findings show that some patients – who were given the drug lecanemab at an early stage and had little 'pathological' change to the brain – even saw improvements in their cognitive scores. The drug was licensed for use in the UK last year after trials found it was the first medication to slow progression of disease. Over 18 months, it was found to have slowed it by 5.7 months. The new findings, from a trial of 478 patients who stayed on the drug for four years, found an average delay of almost 11 months before their disease progressed to the next stage. Remarkable results were seen in a sub-group of patients who had low levels of tau, the protein that accumulates as Alzheimer's progresses. In total, 69 per cent of those in this group had no decline at all over four years, and 56 per cent saw an improvement in their cognitive scores. Prof Christopher Van Dyck, the director of the Alzheimer's Research unit at the Yale school of medicine and the study leader, said: 'The thing I really focus on is the time saved. You will get worse over time, but it will take longer to get there.' He said the findings, presented for manufacturers Eisai, made the case for starting early in treatment of Alzheimer's as 'people with the lowest pathology do tend to do the best'. Experts said the results – presented at the Alzheimer's Association International Conference in Toronto – offered hope that the new class of medicines could 'meaningfully change the course of the disease', not just slow decline in the short-term. They also said there was growing evidence to support earlier prescribing of such drugs, with trials planned shortly to see if similar medications, which appear to have fewer side effects, could one day be used preventively. About one million people in the UK suffer from dementia, with Alzheimer's disease the most common form. Lecanemab is part of a new class of medicines aimed at clearing amyloid plaques, the hallmark of Alzheimer's. Typically, patients with mild dementia see scores rise by between one and two points a year on scoring systems used to track the disease. But across the whole trial group, decline was measured at an increase of just 1.75 points over four years. Results from a separate trial of donanemab, a similar drug, also showed powerful results. The drug is normally given for 18 months, or until amyloid in the brain is cleared. Scientists tracked patients for a total of three years, including the time off the drug. The changes in dementia scores, compared with untreated patients, suggest that those prescribed donenamab had gained between six and 12 months before disease progressed. Dr Sheona Scales, the director of research at Alzheimer's Research UK said: 'These latest findings offer renewed hope that Alzheimer's treatments can meaningfully change the course of the disease, not just slow decline in the short term. 'New long-term data show that the benefits of donanemab may continue even after treatment ends, and people on lecanemab for up to four years maintained cognitive gains, with some even improving. Among those treated early with lecanemab and with low levels of tau, over half showed no decline after four years. 'This is the first wave of disease-modifying treatments for Alzheimer's and, while the progress is encouraging, there are still many pieces of the puzzle we don't yet have.' Dr Scales said studies were helping to address key questions about long-term benefits, but uncertainties remained over what happens in the brain when treatment stops and whether amyloid levels stay low long-term. 'As the evidence grows, it's vital that in the UK we continue to evaluate the potential benefit that the treatments could offer to people with Alzheimer's,' she added. Results from another trial earlier this week suggest that a third treatment called trontinemab, which works in a similar way, but is engineered to reduce side effects, could be the most powerful weapon yet against dementia. The study presented earlier this week found the treatment can clear the devastating plaques associated with Alzheimer's far more rapidly than any current licensed drug. The lack of side effects means it could be offered to large populations. This also means it could be offered at a far lower price than current medications, which require intense monitoring – including regular scans – meaning it is more likely to be funded by the NHS.
Yahoo
22-07-2025
- Business
- Yahoo
EISAI TO PRESENT FOUR-YEAR EFFICACY AND SAFETY DATA ON CONTINUOUS TREATMENT WITH LECANEMAB AT THE ALZHEIMER'S ASSOCIATION INTERNATIONAL CONFERENCE 2025
Latest findings from Eisai's robust Alzheimer's disease (AD) pipeline include results from lecanemab long-term data, an immunoassay for measuring amyloid-β protofibrils in cerebrospinal fluid, and a subcutaneous form of lecanemab for continued treatment of AD AD is a progressive, relentless disease caused by a continuous underlying neurotoxic process that begins before and continues after plaque deposition NUTLEY, N.J., July 21, 2025 /PRNewswire/ -- Eisai Inc. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the company will present the latest findings from its robust Alzheimer's disease (AD) pipeline and research, including our dual-acting, anti-amyloid beta (Aβ) protofibril* antibody for the treatment of AD, lecanemab (generic name, U.S. brand name: LEQEMBI®), and anti-MTBR (microtubule binding region) tau antibody, etalanetug (E2814), at the Alzheimer's Association International Conference (AAIC), being held in Toronto and virtually from July 27 - 31. Eisai will present 21 oral presentations, 24 posters, three (3) symposia and two (2) lecanemab product theaters. Key Oral Lecanemab Presentations Four-year Data: On Wednesday, July 30, as part of the "Developing Topics Session: Innovative Therapeutic Approaches" (8:00 – 8:45 AM EDT), initial four-year findings will be presented on lecanemab from the Phase 3 Clarity AD Open-Label Extension in Early Alzheimer's Disease trial. 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, the subcutaneous formulation for maintenance dosing. 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 A Poster Presentation on Monday, July 28 (viewing available from 7:30 AM – 4:15 PM EDT) 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. Key Oral E2814 Presentation A Featured Research Session on Wednesday, July 30 (4:15 – 5:45 PM EDT) will include findings from the Anti-Tau Etalanetug (E2814) with Lecanemab Therapy in Individuals with Dominantly Inherited Alzheimer's Disease: A First Look at Baseline Characteristics and Impact of 6-Month Lecanemab Treatment on Amyloid PET and Safety in the DIAN-TU-001 NexGen Trial. "The data presented at AAIC 2025 will highlight long-term findings from lecanemab's open-label extension trial, real-world lecanemab case studies as well as results on a subcutaneous formulation and dosing regimen that may offer patients more flexibility to continue treatment to fight Alzheimer's disease," said Lynn D. Kramer, M.D., FAAN, Chief Clinical Officer, Deep Human Biology Learning (DHBL), Eisai. "We will also share preliminary results from the DIAN-TU-001 NexGen Trial, exploring etalanetug with background lecanemab therapy to slow or prevent the progression of Alzheimer's disease. As we gain more experience using dual-acting lecanemab in different clinical settings and continue to explore new avenues to improve the diagnosis and treatment of Alzheimer's disease, we are hopeful about the future. We remain committed to patients and their loved ones who are impacted by this progressive, relentless disease, caused by a continuous underlying neurotoxic process that begins before and continues after plaque is removed from the brain." Key Featured Research Sessions Featured Research Session (FRS), #1-31-FRS-A: Anti-Amyloid Therapies in Clinical Practice: Real World Evidence and Implementation Consideration 4:15 - 5:45 PM EDT, Sunday, July 27 Session Program Indirect Treatment Comparison of ARIA Outcomes for Lecanemab Compared to Donanemab Based on Reported Results (Abstract ID 103048) Featured Research Session, #4-13-FRS-C: Lecanemab Subcutaneous Formulation for Maintenance Dosing: The Potential of a New and Convenient Option for Ongoing Treatment in Early Alzheimer's Disease 9:00 - 10:30 AM EDT, Wednesday, July 30 Session Program Development of Subcutaneous Lecanemab: Establishing the Comparability of Subcutaneous and Intravenous Lecanemab Formulations (Abstract ID 104694) Lecanemab Subcutaneous Formulation for Maintenance Dosing in Early Alzheimer's Disease (Abstract ID 104693) Clinical and Pharmacologic Profile of a Subcutaneous Lecanemab Formulation (Abstract ID 104691) Subcutaneous Lecanemab: Potential Benefits and Place in Therapy (Abstract ID 104695) Featured Research Session, #4-31-FRS-B: Anti-Tau Etalanetug (E2814) with Lecanemab Therapy in Individuals with Dominantly Inherited Alzheimer's Disease: A First Look at Baseline Characteristics and Impact of 6-Month Lecanemab Treatment on Amyloid PET and Safety in the DIAN-TU-001 NexGen Trial 4:15 - 5:45 PM EDT, Wednesday, July 30 Session Program DIAN-TU-001 Trial (Tau NexGen) Rationale and Enrollment Experience (Abstract ID 105298) Baseline Participant Clinical Characteristics in the DIAN-TU-001 Trial (Abstract ID 105299) Baseline Imaging Characteristics of Participants in the Phase II/III DIAN-TU- 001 Tau NexGen Trial for Dominantly Inherited Alzheimer's Disease (Abstract ID 105301) Lecanemab in DIAD: 6-Month Amyloid PET Results from the DIAN-TU-001 Trial (Abstract ID 105303) Safety of Lecanemab After 6-Month Treatment in the DIAN-TU-001 Trial (Abstract ID 105304) Key Developing Topics Sessions Developing Topics On Real-World Data 8:00 - 8:45 AM EDT on Sunday, July 27 Session Program Patient, Care Partner, and Health Care Professional Opinion of the Lecanemab Autoinjector for Subcutaneous Delivery in Early Alzheimer's Disease Patients (Abstract ID 108809) Lecanemab Two Years Post-Approval: Real-World Case Series and Patient Pathway Learnings from Diverse US Clinical Settings 9:00 - 10:30 AM EDT on Sunday, July 27 Session Program Real-World Use of Lecanemab in Patients with Early Alzheimer's Disease in the United States: A Case Series Review (Abstract ID 108599) Real-World Use of Lecanemab with Consideration of Race, Ethnicity and Geographical Diversity (Abstract ID 108602) Real-World Use of Lecanemab in APOE ε4 Homozygotes and in Patients on Antithrombotic Therapy (Abstract ID 108603) Physician Satisfaction with Lecanemab in Early Alzheimer's Disease: Real- World Insights from Prescribers in the United States (Abstract ID 108605) Real-World Insights on the Lecanemab Patient Pathway in Early Alzheimer's Disease in the United States (Abstract ID 108606) Blood-Based Biomarkers in the Lecanemab Patient Pathway for Early Alzheimer's Disease in the United States (Abstract ID 108607) Developing Topics On Innovative Therapeutic Approaches 8:00 - 8:45 AM EDT, Wednesday, July 30 Session Program The Lecanemab Clarity AD Open-Label Extension in Early Alzheimer's Disease: Initial Findings from the 48-Month Analysis (Abstract ID 108905) Additional Featured Research and Developing Topics Sessions Biomarkers July 28 (Mon.) 9:00 – 10:30 AM EDT Featured Research Session, #2-17-FRS-A: Sex Specific Risk And Protective Factors in Alzheimer's Disease Sex-Stratified GWAS Meta-Analyses Reveal Novel Sex-Specific Association with CSF Biomarkers of Alzheimer's Disease (Abstract ID 102560) Lecanemab July 29 (Tues.) 2:00 – 3:30 PM EDT Developing Topics Session: Developing Topics On Tau Biomarkers Variations in Plasma p-Tau217 by Sociodemographic Factors Across World Regions in a Preclinical AD Clinical Trials Program: The AHEAD 3-45 Study (Abstract ID 108909) Clinical Trials July 30 (Weds.) 2:00 – 3:30 PM EDT Featured Research Session, #4-26-FRS-A: Innovative Use of Statistical Models and Machine Learning to Enhance AD Clinical Trials Baseline Predictions of PACC Progression Trajectories in Preclinical AD Improve the Precision and Power of Treatment Effect Assessments (Abstract ID 99560) Poster Presentations Asset/Project,Presentation Date and Time** Title, Abstract Number Lecanemab July 27 (Sun.) Results from a Human Factor Study Supporting Safe and Effective Use of the Lecanemab Subcutaneous Autoinjector (Abstract ID 106273) Lecanemab July 27 (Sun.) Delphi Consensus for Implementation of Anti-Amyloid mAb Initiation in Private Practice Neurology: Preliminary Recommendations from Experienced Providers (Abstract ID 108789) Lecanemab July 28 (Mon.) Target Engagement of Lecanemab on CSF Aβ Protofibril Toxic Species in Clarity AD (Abstract ID 108918) Lecanemab July 28 (Mon.) Understanding Real-World Clinical Experience with Lecanemab: Capturing the Patient and Care Partner Voice Through Social Media Listening (Abstract ID 102018) Lecanemab July 29 (Tues.) Patient and Care Partner Expectations and Emotional Experiences of Lecanemab: A Social Media Listening Study (Abstract ID 101001) Lecanemab July 29 (Tues.) Lecanemab Real-World Use Perspectives from a New England Alzheimer's Disease Center: A Retrospective Chart Review (Abstract ID 101388) Lecanemab July 30 (Weds.) Transitioning from Clinical Trial to Clinical Practice for Long-Term Lecanemab Treatment in Early Alzheimer's Disease: Perspectives from an Alzheimer's Disease Treatment Center (Abstract ID 101400) E2025 July 29 (Tues.) Quantification of EphA4 Turnover Rate and Subsequent Validation of Target Engagement for E2025, a Novel Anti-EphA4 Antibody, in Human Neural Cells (Abstract ID 96834) E2814 July 30 (Weds.) E2814 Mitigates Tau Pathology: Inhibiting Tau Uptake and Promoting MTBR- Tau Clearance Through Microglial Pathways in vitro (Abstract ID 102696) Biomarkers and Imaging July 27 (Sun.) External Validation of Joint Propagation Model-Based Tau PET CenTauR Units (Abstract ID 106362) Biomarkers and Imaging July 28 (Mon.) Identifying Differentially Expressed Proteins Between Amyloid Positive and Amyloid Negative Subjects Based on Alamar Multiplex Assay Data Using MissionAD Samples (Abstract ID 107031) Biomarkers and Imaging July 29 (Tues.) Influence of Demographics and Scan Time on MK6240 Off-Target Signal and Reference Region Selection (Abstract ID 100424) Biomarkers July 27 (Sun.) Observational Study Evaluating Blood-Based Biomarker Use for Confirmatory Alzheimer's Disease Diagnosis in Real-World Clinical Practice Within the United States (Abstract ID 99857) Biomarkers July 28 (Mon.) A De Novo-Assisted Strategy to Identify Novel IncRNA-Encoded Peptides in Cerebrospinal Fluid of Demented Subjects With or Without Amyloid Positivity (Abstract ID 106893) Biomarkers July 28 (Mon.) Impact of Blood-Based Biomarkers on Access to Alzheimer's Disease Treatments: A Simulation Study in Japan (Abstract ID 102553) Biomarkers July 29 (Tues.) Implementation Science Study Evaluating the Real-World Use of Blood-Based Biomarkers as Confirmatory Diagnostic Tools for Alzheimer's Disease in the United States (Abstract ID 99804) Biomarkers July 29 (Tues.) Characterization of Lewy Body Copathology in Early AD Clinical Trial Population Demonstrates Similarities and Differences Compared to Natural History Studies in Alzheimer's Disease Patients (Abstract ID 107102) Biomarkers July 30 (Weds.) Value of Blood-Based Biomarker Testing to Diagnose, Identify and Monitor Patients with Alzheimer's Disease: A Structured Literature Review (Abstract ID 99842) Biomarkers July 30 (Weds.) Alzheimer's Disease Molecular Subtypes in a Clinical Trial Cohort (Abstract ID 105257) General AD July 27 (Sun.) Operational Consideration and Best Practices for Implementation of an Early Alzheimer's Disease Patient Care Pathway (Abstract ID 108093) General AD July 27 (Sun.) Estimating Clinical Transitions in Patients with Alzheimer's Using Instrumental Activities of Daily Living (IADL) (Abstract ID 107058) General AD July 28 (Mon.) Staging Alzheimer's Disease Using the Functional Assessment Screening Tool (FAST): A Crosswalk with the Montreal Cognitive Assessment (MoCA) (Abstract ID 107045) General AD July 29 (Tues.) Time to Alzheimer's Disease Diagnosis in Japan: A Retrospective Observational Study (Abstract ID 97026) General AD July 30 (Weds.) Alzheimer's Disease Staging by Instrumental Activities of Daily Living (IADL): A Crosswalk with the Montreal Cognitive Assessment (MoCA) (Abstract ID 107009) **Poster viewing time is set from 7:30 AM – 4:15 PM EDT on the date of presentation Eisai-Sponsored Symposia Asset/Project,Presentation Date and Time Title General AD July 28 (Mon.) 6:00 – 7:30 PM EDT Smoldering Alzheimer's Disease: The Ongoing Benefit of Addressing Multiple Pathologies General AD July 30 (Weds.) 6:15 – 7:45 AM EDT Unlock Your Brain: Exploring Alzheimer's Disease from the Inside Out General AD July 30 (Weds.) 6:00 – 7:30 PM EDT Brain Health Navigator—Ensuring Efficient and Effective Alzheimer's Disease Diagnostic and Clinical Care Pathways Eisai-Sponsored Product Theaters Asset/Project,Presentation Date and Time Title Lecanemab July 27 (Sun.) 12:25 – 1:05 PM EDT Early Diagnosis, Early Treatment: Identifying Patients for Greater Benefit in Mild Cognitive Impairment Due to Alzheimer's Disease Lecanemab July 28 (Mon.) 12:25 – 1:05 PM EDT Best Practices in Early Alzheimer's Disease Care: Creating a Plan from Screening Through Long-Term Treatment Product theaters will feature presentations based on real-world clinical experience with lecanemab - providing attendees with an opportunity to hear best practices and expert guidance on using this therapy. This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval. * Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.1 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.2 MEDIA CONTACTSEisai Inc. (U.S.)Julie Edelman+1-862-213-5915Julie_Edelman@ [Notes to editors] About lecanemab (LEQEMBI®)Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab is approved and being marketed in the U.S.,3 Japan,4 China,5 South Korea,6 Hong Kong,7 Israel,8 the United Arab Emirates,9 the United Kingdom,10 Mexico,11 Macau,12 Oman, Taiwan,13 European Union,14 Qatar, Singapore15 and Thailand16 for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). Eisai has submitted applications for approval of lecanemab in 11 countries and July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. About the Collaboration between Eisai and Biogen for ADEisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. About the Collaboration between Eisai and BioArctic for ADSince 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015. References Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi: 10.1038/s41467-021-23507-z. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706. U.S. Food and Drug Administration. 2023. FDA Converts Novel Alzheimer's Disease Treatment to Traditional Approval. Last accessed: July 2025. Reuters. 2023. Japan approves Alzheimer's treatment Leqembi by Eisai and Biogen. Last accessed: July 2025. The Pharma Letter. 2024. Brief - Alzheimer drug Leqembi now approved in China. Last accessed: July 2025. Pharmaceutical Technology. 2024. South Korea's MFDS approves Eisai-Biogen's LEQEMBI for Alzheimer's. Last accessed: July 2025. Pharmaceutical Technology. 2024. Hong Kong approves Leqembi for Alzheimer's treatment. Last accessed: July 2025. Israel Ministry of Health. The Israeli Drug Registry. Leqembi. Last accessed: July 2025. United Arab Emirates Ministry of Health & Prevention. 2024. Registered Medical Product Directory. Leqembi. Last accessed: July 2025. BioSpace. 2024. Leqembi authorized for early Alzheimer's disease in Great Britain. Last accessed: July 2025. COFEPRIS authorizes innovative treatment for Alzheimer's patients. Available at: Last accessed: July 2025. Macau Special Administrative Region Drug Search. Last accessed: July 2025. Taiwan Food and Drug Administration Assessment Report. Last accessed: July 2025. European Medicines Agency. Leqembi | European Medicines Agency (EMA). Last accessed: July 2025. Health Sciences Authority. Last accessed: July 2025. Thailand Food and Drug Administration, Ministry of Public Health. Last accessed: July 2025. View original content to download multimedia: SOURCE Eisai Inc.
Japan Times
10-07-2025
- Health
- Japan Times
Japan to cut price of Alzheimer's drug lecanemab
Japan is expected to lower the price of lecanemab, an Alzheimer's drug codeveloped by Japanese drugmaker Eisai and Biogen of the United States, following a health ministry panel's report citing its low cost-effectiveness. Based on the assessment report, the ministry is expected to cut the official price of the drug by up to 15% from the current level of about ¥3 million per patient a year. The report, submitted to the Central Social Insurance Medical Council, which advises the health minister, on Wednesday, pointed to lecanemab's lower cost-effectiveness compared with conventional Alzheimer's drugs such as donepezil. The margin of the expected price cut will be formally decided after the council discusses lecanemab's effect in reducing costs of public nursing care services. Lecanemab is innovative because it removes abnormal proteins that accumulate in patients' brains, hopefully slowing the progression of the disease. As the number of dementia patients is expected to increase rapidly due to the aging population, there are concerns that the expensive drug will pressure the finances of the nation's public health insurance programs. Eisai rebutted the ministry panel's report, arguing that lecanemab's cost-effectiveness has been underestimated. While noting that the company and the panel used different analytical models, Eisai emphasized that its analysis better reflects the value of the drug.
