“LEQEMBI” Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Israel By Investing.com

TOKYO and CAMBRIDGE, Mass., July 12, 2024 – (JCN NewsWire) – Eisai Co., Ltd. (OTC:) and Biogen Co., Ltd. (NASDAQ:) today announced the approval of the beta-amyloid (Aβ)-degrading monoclonal antibody “LEQEMBI” (generic name: lecanemab) in Israel as a treatment for Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of the disease (collectively referred to as early AD), the population in which the treatment was initiated in clinical trials.

LEQEMBI selectively binds to soluble beta-amyloid aggregates (prefibrils) as well as insoluble beta-amyloid aggregates (fibrils) that are a major component of beta-amyloid plaques, thereby reducing both prefibrils and beta-amyloid plaques in the brain. LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and slow cognitive and functional decline through this mechanism. LEQEMBI is also approved in the United States, Japan, China, South Korea, and Hong Kong, and is marketed in the United States, Japan, and China.

The approval of LEQEMBI is based on the large, global, Phase 3 Clarity AD study. In the Clarity AD study, LEQEMBI met the primary endpoint and all key secondary endpoints with statistically significant results.(1),(2)

Eisai is responsible for the development and regulatory submission of Lecanemab globally, with Eisai and Biogen jointly marketing and promoting the product, and Eisai having final decision-making authority. Eisai will market LEQEMBI in Israel.

Protofibrils are thought to contribute to the brain injury that occurs in Alzheimer’s disease and are the most toxic form of beta-aminobutyrate that plays a key role in the cognitive decline associated with this progressive and debilitating condition. (3) Protofibrils cause injury to neurons in the brain, which in turn can negatively impact cognitive function through multiple mechanisms, not only by increasing the development of insoluble beta-aminobutyrate plaques but also by directly damaging brain cell membranes and the connections that transmit signals between neurons or neurons and other cells. It is thought that reducing protofibrils may prevent the development of Alzheimer’s disease by reducing damage to brain neurons and cognitive impairment. (4)

About Lecanemab (Lekimbe)

Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is an IgG1 monoclonal antibody directed against the soluble (protofibril) and insoluble forms of beta-amyloid (Abeta).

The FDA approval of LEQEMBI was based on data from the global Phase 3 Clarity AD clinical trial conducted by Eisai, in which the primary endpoint and all key secondary endpoints were met with statistically significant results.(1),(2) The primary endpoint was a global cognitive and functional measure, the Clinical Dementia Rating-Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with LEQEMBI reduced clinical deterioration on the CDR-SB by 27% at 18 months compared with placebo. The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted mean least-squares change from baseline at 18 months was 1.21 with LEQEMBI and 1.66 with placebo (difference, -0.45; 95% confidence interval (CI), -0.67 to -0.23; P < 0.001). In addition, the secondary endpoint of the Collaborative Study of Activities of Daily Living for Mild Cognitive Impairment (ADCS-MCI-ADL) score, which measures information provided by caregivers of patients with the disease, showed a statistically significant benefit of 37% compared with placebo. The adjusted mean change from baseline at 18 months in ADCS-MCI-ADL score was -3.5 in the LEQEMBI group and -5.5 in the placebo group (difference, 2.0; 95% CI, 1.2 to 2.8; P <0.001). يقيم مقياس ADCS MCI-ADL قدرة المرضى على العمل بشكل مستقل، بما في ذلك القدرة على ارتداء الملابس وإطعام أنفسهم والمشاركة في الأنشطة المجتمعية. كانت الأحداث السلبية الأكثر شيوعًا (>10% in the LEQEMBI group were infusion reactions, ARIA-H (combined microcerebral hemorrhage, macrocephalic hemorrhage, and superficial cerebral fibrosis), ARIA-E (edema/effusion), headache, and falls.

LEQEMBI has been approved in the United States, Japan, China, South Korea, and Hong Kong for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild dementia due to Alzheimer’s disease. Eisai has also filed for approval of LEQEMBI in 12 countries and regions, including the European Union. A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the U.S. Food and Drug Administration (FDA) in March 2024, which was accepted in June 2024. A continued filing for a Biologics License Application (sBLA) for maintenance dosing for a subcutaneous injection formulation, which is being developed to enhance patient convenience, was initiated in the United States under fast-track status in May 2024.

Since July 2020, a Phase 3 clinical study (AHEAD 3-45) has been ongoing in individuals with preclinical Alzheimer’s disease, meaning they are clinically normal and have moderate or high levels of amyloid in their brains. AHEAD 3-45 is being conducted as a public-private partnership between the Alzheimer’s Disease Clinical Trials Consortium, which provides the infrastructure for academic clinical trials in Alzheimer’s disease and related dementias in the United States, with funding from the National Institute on Aging, part of the National Institutes of Health, Eisai, and Biogen. Since January 2022, the Tau NexGen clinical study in autosomal dominant Alzheimer’s disease (DIAD), conducted by the Autosomal Dominant Alzheimer’s Disease Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has been ongoing and includes lecanemab as a frontline anti-amyloid treatment.

About the cooperation between Eisai and Biogen in the field of Alzheimer’s disease

Eisai and Biogen have been collaborating on the co-development and commercialization of Alzheimer’s disease therapies since 2014. Eisai is leading the development of lecanemab and regulatory submissions globally, with Eisai and Biogen jointly marketing and promoting the product, and Eisai having final decision-making authority.

About Eisai and BioArctic Collaboration for Alzheimer’s Disease

Since 2005, Eisai and BioArctic have had a long-term collaboration in the development and commercialization of Alzheimer’s disease therapies. Eisai acquired the global rights to study, develop, manufacture and commercialize Lecanemab for the treatment of Alzheimer’s disease under an agreement with BioArctic in December 2007. The development and commercialization agreement for the antibody Lecanemab was signed in May 2015.

About Eisai Co., Ltd.

Eisai’s corporate philosophy is to “prioritize patients and people in everyday life, and maximize the benefits of healthcare.” Under this concept (also known as the Human Healthcare Concept), we aim to effectively achieve social good in the form of alleviating health anxiety and reducing health disparities. Through a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with unmet medical needs, with a particular focus on our strategic areas of neuroscience and oncology.

Furthermore, we demonstrate our commitment to eliminating neglected tropical diseases, one of the targets (3.3) of the United Nations Sustainable Development Goals, by working on various activities in collaboration with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai, Inc.) or www.eisai.eu (for EMEA, Russia, Australia and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on X (global and U.S.), LinkedIn (global, U.S. and EMEA) and Facebook (NASDAQ:) (global).

About Biogen

Founded in 1978, Biogen is a leading biotechnology company that creates innovative science to deliver new medicines that transform patients’ lives and create value for shareholders and our communities. We apply our deep understanding of human biology and leverage diverse approaches to develop breakthrough therapies or treatments that deliver superior outcomes. Our approach is to take bold risks, while generating a return on investment for long-term growth.

The Company routinely posts information that may be important to investors on its website www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube

References

(1) Eisai presents full results from the Clarity AD confirmatory phase 3 study of lecanemab for early Alzheimer’s disease at the Clinical Trials for Alzheimer’s Disease (CTAD) conference. Available at: https://www.eisai.com/news/2022/news202285.html

(2) Van Dyke, H., et al. Lecanemab in early Alzheimer’s disease. The New England Journal of Medicine. 2023;388:9-21. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948.

(3) Amin L, Harris DA. Amyloid beta receptors specifically recognize molecular features displayed by fibril endings and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z4. Ono K, Tsuji M. Amyloid beta precursor fibrils are important targets for disease-modifying approaches to Alzheimer’s disease. International Journal of Medical Sciences. 2020;21(3):952. doi:10.3390/ijms21030952. PMID:32023927; PMCID:PMC7037706.

Media contact:

Eisai Co., Ltd.

public relations section

Phone: +81 (0)3-3817-5120

Biogen Corporation

Jack Cox

+1-781-464-3260

Public Affairs@biogen.com

Investor Contacts:

Eisai Co., Ltd.

Investor Relations Department

Phone: +81 (0) 3-3817-5122

Biogen Corporation

Chuck Triano

+1-781-464-2442

IR@biogen.com

Safe Haven from Biogen

This press release contains forward-looking statements regarding the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and their timing; the treatment of Alzheimer’s disease; the anticipated benefits and potential of the collaboration arrangements between Biogen and Eisai; the potential of Biogen’s business and pipeline programs, including lecanemab; and the risks and uncertainties associated with the development and commercialization of drugs. These statements can be identified by words such as “target,” “expect,” “believe,” “could,” “estimate,” “anticipate,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in the commercialization of a product. Results in early-phase clinical studies may not be indicative of the full results or results of later-phase or larger-scale clinical studies and do not guarantee regulatory approval. You should not place undue reliance on these statements.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, but not limited to, unanticipated concerns that may arise from additional data, analysis or results obtained during clinical studies; the occurrence of adverse safety events; the risk of unexpected costs or delays; the risk of other unanticipated obstacles; regulatory applications may take longer or be more difficult to complete than anticipated; regulatory authorities may require additional information or other studies, or may fail or deny approval or delay approval of Biogen’s drug candidates, including lecanemab; the actual timing and content of applications submitted to and decisions made by regulatory authorities regarding lecanemab; uncertainty regarding the successful development and commercialization of potential lecanemab; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainty regarding intellectual property claims and challenges; product liability claims; and risks of collaboration with third parties and results of operations and financial condition. The foregoing identifies many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement in addition to the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release. Biogen undertakes no obligation to update any forward-looking statements publicly.

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