lecanemab

Lecanemab Receives Priority Review Status in Japan

ruth 30 1 月

2 minutes

TOKYO and CAMBRIDGE, Mass., Jan 30, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that an application for manufacturing and marketing approval for lecanemab (generic name, U.S. brand name: LEQEMBI), an anti-amyloid-beta (Abeta) protofibril* antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare (MHLW). Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened. In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively binds and eliminates soluble, toxic Abeta aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. As such, lecanemab may have the potential to have an effect on di...

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer’s Disease in Japan

ruth 16 1 月

3 minutes

TOKYO and CAMBRIDGE, Mass., Jan 16, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a marketing authorization application for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril(1) antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA).This application is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab. In the Clarity AD study, lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale as the primary endpoint (CDR-SB(2): Clinical Dementia Rating-Sum of Boxes) as early as six mon...

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Europe

ruth 11 1 月

3 minutes

TOKYO, Jan 11, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) to the European Medicines Agency (EMA). This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD, and is subject to a validation to determine whether the EMA accepts the application for review.The Clarity AD study met its primary endpoint (CDR-SB(1): Clinical Dementia Rating-Sum of Boxes) and all key secondary endpoints with highly statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.In Nove...

Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference

ruth 30 11 月

3 minutes

TOKYO, Nov 30, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, in San Francisco, California and virtually.Figure 1: CDR-SB as Primary endpoint change (18 months)Summary of Presentations in the Scientific Session featuring Lecanemab at CTADDesign of Clarity AD StudyEisai's Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 898 placebo group: 897) at 235 sites in North America, Europe, and Asia. The participants were randomized 1:1 to receive either placebo or lecanemab 10-mg/kg IV biweekly, and the randomization was stratified according to clinical subgroup (MCI due to AD...

Eleven Experts from Leading Medical Institutions and Eight Experts from Eisai Publish Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease in the New England Journal of Medicine

ruth 30 11 月

2 minutes

TOKYO, Nov 30, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, were published in the New England Journal of Medicine, one of the world's most prestigious peer-reviewed medical journals. For the details of the paper, please refer to: www.nejm.org/doi/full/10.1056/NEJMoa2212948.The rapid publication of the Clarity AD study results demonstrates Eisai's strong commitment to trust and transparency based on Eisai's human health care mission. Eisai and Biogen remain committed to disclosing data and information on lecanemab. If approved, we will work to bring the drug expeditiously to people living with early AD and their families.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-p...

Eisai to Present Full Findings from Lecanemab Confirmatory Phase 3 Clinical Trial (Clarity AD) and Other Alzheimer’s Disease Research at The 15th Clinical Trials on Alzheimer’s Disease (CTAD) Conference

ruth 21 11 月

4 minutes

TOKYO, Nov 21, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. will present the efficacy, safety and biomarker findings from the company's Phase 3 confirmatory Clarity AD clinical trial for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the potential treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, at the 15th Clinical Trials on Alzheimer's Disease (CTAD) conference. At the meeting, which will be held in San Francisco, CA and virtually from November 29 to December 2, Eisai and esteemed faculty will present the full data in a scientific session on the first day of the meeting (November 29 at 4:50 p.m. PT). Additionally, other important research from the lecanemab clinical development program and Eisai's AD pipeline, including the company's investigational anti-microtubule binding region (MTBR) tau antibody (E2814), will be presented in four oral and ten poster presentations.Topline results from Clarity AD were announced in late September and showed that lecanemab met the primary end...

Eisai’s Lecanemab Confirmatory Phase 3 Clarity AD Study Met Primary Endpoint

ruth 28 9 月

6 minutes

TOKYO, Sep 28, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced positive topline results from Eisai's large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. Lecanemab met the primary endpoint (CDR-SB: Clinical Dementia Rating-Sum of Boxes*) and all key secondary endpoints with highly statistically significant results. Eisai will discuss this data with regulatory authorities in the U.S., Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of Eisai's FY2022, which ends March 31, 2023. Additionally, Eisai will present the Clarity AD study results on November 29, 2022, at the Clinical Trials on Alzheimer's Congress (CTAD), and publish the findings in a peer-reviewed medical journal.Lecanemab treatment met the primary endpoint and reduced clinica...

Eisai Presents New Findings on Lecanemab’s Investigational Subcutaneous Formulation and Modeling Simulation of ApoE4 Genotype on Aria-E Incidence at AAIC 2022

ruth 4 8 月

5 minutes

TOKYO and CAMBRIDGE, Mass., Aug 4, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced that Eisai presented new findings on a subcutaneous formulation of lecanemab (BAN2401) and the modeling simulation of the impact of ApoE4 genotype on the incidence of amyloid-related imaging abnormalities - edema/effusion (ARIA-E) - in subjects treated with lecanemab, an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. The data were shared at the Alzheimer's Association International Conference (AAIC) in San Diego, CA.Key Eisai presentations include:Eisai Abstract #69438: Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Lecanemab in Healthy SubjectsThis Phase 1 study was an open-label, parallel-group study conducted in healthy subjects: 30 subjects were randomized into a 10 mg/kg intravenous (IV) dose group and 29 subjects (5 of which were Japanese) were randomized into a single fixed 700mg SC dose group. The absolute bioavailability of lecanemab fol...

Eisai Publishes Potential Economic Value of Investigational Lecanemab in Peer-Reviewed Neurology and Therapy Journal

ruth 22 6 月

7 minutes

TOKYO, Jun 22, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. today announced publication of results from an early phase evaluation that aimed to estimate potential economic value of its investigational anti-amyloid-beta (Abeta) protofibril antibody lecanemab in people living with early Alzheimer's disease (AD) using a validated disease simulation model, AD Archimedes Condition Event (AD ACE) model1,2,3 from the healthcare payer and societal perspectives in the United States, in the peer-reviewed journal Neurology and Therapy. This is the second publication of lecanemab's potential value. It follows the evaluation of the long-term health outcomes using simulation modeling of lecanemab published in Neurology and Therapy in April 2022.4 While the healthcare payer perspective focuses on direct care costs (e.g., outpatient and inpatient services, medications, intervention costs, nursing home and home healthcare services), the societal perspective further considers societal costs (e.g., productivity loss and informal care costs). As reported in the previous publication, it was suggested that compared to standard of care* (SoC), individuals treated with lecanemab in addition t...

Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathway

ruth 10 5 月

9 minutes

TOKYO and CAMBRIDGE, Mass., May 10, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401) for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. As part of the completed rolling submission, Eisai has requested Priority Review. If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Dependent upon the results of the C...

Eisai: Latest Findings on Lecanemab Presented at AD/PD 2022 Annual Meeting

ruth 22 3 月

10 minutes

CAMBRIDGE, Mass., and TOKYO, Mar 22, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the latest findings on lecanemab, an investigational anti-amyloid-beta (Abeta) protofibril antibody being developed for the treatment of early Alzheimer's disease (AD), were presented at the Abeta Targeted Therapies in AD 2 Symposium at the 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) March 15-20 in Barcelona, Spain and virtually.Four key symposium presentations explored how lecanemab's clinical efficacy data, overall amyloid-related imaging abnormality (ARIA) rates, biomarker relationships to clinical outcomes, potential dosing regimens, and administration have the potential to benefit people living with early AD.1. Science of the Amyloid Cascade and Distinct Mechanism of Action (MoA) of Lecanemab- BioArctic's Professor Lars Lannfelt presented the science of the amyloid cascade and studies evaluating lecanemab's distinct binding profile to antibodies created from patented sequences of two other clinical antibodies, aducanumab and gantenerumab. The three antibodies have different binding profiles to Abeta species. All t...

Biogen and Eisai Amend Collaboration Agreements on Alzheimer’s Disease Treatments

ruth 15 3 月

7 minutes

CAMBRIDGE, Mass., and TOKYO, Mar 15, 2022 - (JCN Newswire via SEAPRWire.com) - Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. announced today that the companies have amended their existing collaboration agreement on aducanumab, which is commercialized in the United States as ADUHELM (aducanumab-avwa). Effective as of January 1, 2023, Eisai will receive a tiered royalty based on net sales of ADUHELM rather than sharing global profits and losses. The royalty rate starts at 2% and reaches 8% when annual sales exceed $1 billion. Effective immediately Biogen's existing final decision-making rights on ADUHELM have converted to sole decision making and commercialization rights worldwide. Overall, economic arrangements for both companies in 2022 are expected to remain materially unchanged with Eisai's share of expenses capped at an agreed amount for the costs related to development, commercialization and manufacturing of ADUHELM for the period from January 1, 2022, to December 31, 2022. Once the tiered royalty model commences on January 1, 2023, Eisai will not participate in ADUHELM's economics beyond these royalties. The companies will continue to jointly develop and commercialize the inv...

Eisai Initiates Submission of Application Data Under the Prior Assessment Consultation System in Japan with the Aim of Obtaining Early Approval for Investigational Anti-Amyloid Beta Protofibril Antibody Lecanemab

ruth 4 3 月

9 minutes

TOKYO, Mar 4, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401). The lecanemab Clarity AD Phase 3 clinical study for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) is ongoing.The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time. Based on discussions with the Ministry of Health, Labour and Welfare (MHLW) and PMDA, Eisai applied to PMDA for permission to utilize the "prior assessment consultation" process for lecanemab with the aim of shortening the review period. The agency approved Eisai's request and Eisai has submitted the non-clinical lecanemab data ...

Eisai Presents New Analysis of Lecanemab Clinical Efficacy Results from Phase 2b Study at Clinical Trials On Alzheimer’s Disease (CTAD) Conference

ruth 12 11 月

3 minutes

TOKYO and CAMBRIDGE, Mass., Nov 12, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today results of sensitivity analyses evaluating the consistency of lecanemab efficacy results across multiple statistical models in patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD). This presentation was made by Eisai at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference, November 9-12, 2021 in Boston, Massachusetts and virtually. In September 2021, Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. Study 201, a multicenter, double-blind, placebo-controlled, Phase 2b trial conducted in 856 patients with early AD, evaluated key efficacy assessments, including clinical change on the Alzheimer's Disease Composite Score (ADCOMS) at the primary endpoint of 12 months and at select key secondary endpoints, Clinical Dementia Rating-Sum-of-Boxes (CDR-SB) and Alzheimer's...

Eisai Presents Late-Breaker Updates on Lecanemab Clinical, Biomarker and Safety Data from Phase 2b Study Core and Open-Label Extension

ruth 11 11 月

4 minutes

TOKYO, Nov 11, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today results of new clinical, biomarker and safety assessments of brain amyloid reduction and five-year clinical status of people living with early Alzheimer's disease (AD) from the lecanemab Phase 2b 201 and the open-label extension (OLE) studies. The findings were presented and discussed in a late-breaking roundtable session with esteemed clinical researchers at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference, November 9-12, 2021, in Boston, Massachusetts and virtually. Eisai recently initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway.OLE Study Explores Biomarkers and Clinical Effects Across Five YearsAn OLE with 10 mg/kg IV biweekly lecanemab dosing was implemented after analysis of the 18-month, core phase (Study 201, Alz Res Therapy 13;21) with an intervening off-treatment period (gap period) ranging from 9-59 months (mean 24 months). The ...

Eisai Presents New Data on the Relationship Between Clinical, Biomarker and Safety Outcomes from the Lecanemab Phase 2B Study

ruth 4 11 月

2 minutes

TOKYO, Nov 4, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today the presentation of data from the company's extensive Alzheimer's disease (AD) pipeline, including six oral presentations that will provide deeper insights into lecanemab's potential as a treatment for early AD. Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway in September 2021. The lecanemab data and additional research findings from Eisai's robust AD pipeline will be featured in 10 presentations, including five late breaker oral presentations, at the 14th Clinical Trials on Alzheimer's Disease (CTAD) conference, November 9-12, 2021, in Boston, Massachusetts and virtually."The findings Eisai will present at CTAD provide scientific insights into the potential role of lecanemab in the treatment of early Alzheimer's disease as well as the relationship between clearance of amyloid-beta plaque from the brain, changes in blood-based biomarkers and clinical outcomes," said Mich...

Eisai Initiates Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab (BAN2401) for Early Alzheimer’s Disease Under the Accelerated Approval Pathway

ruth 28 9 月

6 minutes

TOKYO, Sep 28, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. today announced that Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401), the company's investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer's disease (early AD). The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in people with early AD and confirmed amyloid pathology. The lecanemab Phase 2b trial results demonstrated a high degree of Abeta plaque lowering and consistent reduction of clinical decline across several clinical endpoints. The correlation between the extent of Abeta plaque reduction and effect on clinical endpoints in Study 201 further supports Abeta as a surrogate endpoint that is reasonably likely to predict clinical benefit. AD is a serious, progressive and devastating disease with few treatment options. Eisai is utilizing the accelerated approval pathway after discussion with the FDA and aims to bring a new trea...

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab (BAN2401)

ruth 30 7 月

5 minutes

TOKYO, Jul 30, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. today announced results of a longitudinal preliminary assessment of the clinical effects of lecanemab (development code: BAN2401) -- granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in June 2021 -- following 18 months of treatment in the open-label extension (OLE) of the Phase 2b proof-of-concept study in subjects with early Alzheimer's disease (AD) (Mild Cognitive Impairment [MCI] due to AD and mild AD) at the Alzheimer's Association International Conference (AAIC) held in Denver, Colo., United States and virtually from July 26 to 30, 2021 (Presentation No.: 57780).Lecanemab Study 201 and OLELecanemab is an investigational humanized monoclonal antibody that preferentially binds to soluble amyloid- beta (Aβ) aggregates (protofibrils). Lecanemab reduced brain Aβ and slowed clinical decline in an 18-month Phase 2b proof of concept study (Study 201, n=856) in early AD (Alz Res Therapy 13; 2021). After analysis of the core study, there was an off-treatment gap period of 9-59 months (period of time between the last dose of lecanemab in the cor...

Eisai and Biogen Inc. Announce U.S. FDA Grants Breakthough Therapy Designation for Lecanemab (BAN2401)

ruth 24 6 月

2 minutes

TOKYO, Jun 24, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer's disease (AD). Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. The benefits of a Breakthrough Therapy designation include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review. The FDA's Breakthrough Therapy designation for lecanemab is based on the recently published results of a Phase 2b clinical trial (Study 201) of 856 patients with mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology.1 The proof-of-concept Study 201 explored the impact of treatment with lecanemab on reducing brain amyloid beta (Abeta) and clinical decline. In this study, pre-specified analysis showed consistent reduction of clinical decline across several clinical a...

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