TOKYO and CAMBRIDGE, Mass., Jul 11, 2024 – (JCN Newswire) – – Eisai Co (OTC:)., Ltd. and Biogen Inc (NASDAQ: ). Today announced that the Ministry of Health in HongKong has approved the anti-human soluble amyloid-beta (Abeta) monoclonal antibody “LEQEMBI” (brand name in Hong Kong: generic name: lecanemab) for the treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia disease stages (collectively termed early AD), the population in which treatment was initiated in clinical trials.
LEQEMBI selectively binds to soluble Abeta aggregates (protofibrils), as well as insoluble Abeta aggregates (fibrils) that are the main components of Abeta plaques, thereby reducing Abeta protofibrils and Abeta plaques in the brain. LEQEMBI is the first approved treatment shown to slow the rate of disease progression and reduce cognitive and functional decline through this mechanism. Hong Kong is the fifth agreement, following agreements in the US, Japan, China, and South Korea.
The approval of LEQEMBI in Hong Kong 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) In Hong Kong, 9.3% of people aged 70 years and older have dementia, an increase making up 32% of those aged 85 and over. Of those suffering from dementia, 73.5% were reported to have Alzheimer’s disease.(3),(4)
Eisai is leading lecanemab’s development and regulatory submission globally with Eisai and Biogen jointly commercializing and promoting the product and Eisai having final decision-making authority. Eisai will distribute LEQEMBI in Hong Kong.
Protofibrils are believed to cause the brain injury that occurs with AD and are thought to be the most toxic form of Abeta that plays a major role in the cognitive decline associated with this progressive and destructive condition.(5) Protofibrils cause the tone of injury in the brain. , which can also affect cognitive function through various mechanisms, not only increasing the development of insoluble Abeta plaques but also increasing direct damage to brain cell membranes and connections that transmit signals between nerve cells or nerve cells and other cells. It is believed that the reduction of protofibrils can prevent the progression of AD by reducing neuronal damage in the brain and cognitive dysfunction.(6)
About lecanemab (LEQEMBI)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is an immunoglobulin gamma1 (IgG1) monoclonal antibody directed against the soluble (protofibril) and insoluble forms of amyloid-beta (Abeta).
FDA approval of LEQEMBI is based on Phase 3 data from Eisai’s global Clarity AD clinical trial, which met the primary endpoint and all primary secondary endpoints with statistically significant results.1,2 The primary endpoint was the global cognitive and functional scale, Dementia Clinical Rating Number of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with LEQEMBI reduced clinical decline in CDR-SB by 27% at 18 months compared to placebo. The mean CDR-SB score at baseline was approximately 3.2 in both groups. The 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 AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by caregivers of AD patients, recorded a statistically significant benefit of 37% compared to placebo. The adjusted mean change from baseline at 18 months in the 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). ADCS MCI-ADLasses kemampuan saka patients kanggo fungsi independen, kalebu bisa sugih, Feed piyambak lan melu ing kegiatan masyarakat. Efek samping sing paling umum (> 10%) in the LEQEMBI group were infusion reactions, ARIA-H (combination of cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and falls.
LEQEMBI is approved in the US, Japan, China and South Korea for the treatment of MCI due to AD and mild AD dementia. Eisai has also submitted applications for the approval of LEQEMBI in 13 countries and regions, including the European Union(EU). A supplemental Biologics License Application (sBLA) for intravenous maintenance doses was submitted to the USFood and Drug Administration (FDA) in March 2024, which was accepted in June 2024. The submission of the Biologics License Application (BLA) for maintenance doses of a subcutaneous injection formulation, which was developed for increasing convenience for patients, starting in the US in Fast Track status in May 2024.
As of July 2020, a Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning clinically normal and with moderate or high levels of amyloid in the brain, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between Alzheimer’s Clinical Trials
A consortium that provides infrastructure for academic clinical trials in AD and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Beginning in January 2022, the Tau NexGen clinical study for Inherited Dominant AD (DIAD), conducted by the Inherited Dominant Alzheimer’s Network Trials Unit (DIAN-TU), led by the Washington University School of Medicine in St. Louis, is underway and includes lecanemab as a spinal anti-amyloid therapy.
About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been cooperating in the joint development and commercialization of AD treatment since 2014. Eisaiserves is the lead in the development of lecanemab and the global regulatory submission with Eisai and Biogen co-commercialize and co-promote the product and Eisai has the authority to make the final decision.
About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration on the development and commercialization of AD treatments. Eisai acquired the global rights to study, develop, manufacture and market lecanemab for the treatment of AD under an agreement with BioArctic in December 2007. The development and commercialization agreement on the back-up lecanemab antibody was signed in May 2015.
About Eisai Co., Ltd.
Eisai Company’s concept is “to give first thought to patients and people in the domain of daily life, and to increase the benefits provided by health care.” In this Concept (also known as Human health care Concept (hhc), we aim to effectively achieve social good by eliminating health concerns and reducing health disparities. With a global network of R&Dfacilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with unmet medical needs, with a special focus on the strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the Sustainable Development Goals (SDGs) of the United Nations, by working on various activities together with global partners.
For more information about Eisai, visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us onX, LinkedIn and Facebook (NASDAQ:). Our website and social media channels are aimed at audiences outside the UK and Europe. For audiences based in the UK and Europe, visit www.eisai.eu and Eisai EMEA LinkedIn.
About Biogen
Founded in 1978, Biogen is a biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and create value for our shareholders and our communities. We use our deep understanding of human biology and use multiple modalities to advance first-class treatments or therapies that produce superior results. Our approach is to take bold risks, balanced with investment returns to generate long-term growth.
The company regularly posts important information for investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.
(1) Eisai presents the full results of the lecanemab Phase 3 confirmatory Clarity AD study for early Alzheimer’s disease in Clinical Trials at the Alzheimer’s Disease Conference (CTAD). Available at: www.eisai.com/news/2022/news202285.html
(2) van Dyck, H., et al. Lecanemab in Early Alzheimer’s Disease. New England Journal of Medicine. 2023;388:9-21. www.nejm.org/doi/full/10.1056/NEJMoa2212948.
(3) Department of Health – Dementia Care Seminar Press Release and Kick-off Ceremony for the Dementia Care Campaign. Available at: https://www.dh.gov.hk/english/press/2006/061013.html
(4) Ruby Yu, et al. Trends in Dementia Prevalence and Mortality in Hong Kong’s Elderly Population: Projections, Burden of Disease, and Implications for Long-Term Care. Int J Alzheimer Dis. 2012(7593):406852. doi: 10.1155/2012/406852
(5) Amin L, Harris DA. The abeta receptor specifically recognizes the molecular features displayed by the ends of neurotoxic fibrils and oligomers. Nat Commun. 2021;12:3451. doi: 10.1038/s41467-021-23507-z
(6) Ono K, Tsuji M. Protofibrils of Amyloid-beta as Important Targets of Disease Modification Approaches to Alzheimer’s Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.
Biogen Safe Harbor
This news release contains forward-looking statements, regarding the potential clinical effects of lecanemab; potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and their timing; treatment of Alzheimer’s disease; the anticipated and potential benefits of Biogen’s collaborative arrangement with Eisai; the potential of Biogen’s commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements can be identified by words such as “intend,” “anticipate,” “believe,” “may,” “estimate,” “expect,” “forecast,” “intend,” “could,” “plan,” ” maybe,” “potential,” “will,” “would” and other words and similar terms. The development and commercialization of these drugs carries high risks, and only a few research and development programs lead to the commercialization of products. Results in early stage clinical studies may not be indicative of the full results or results of subsequent or larger scale clinical studies and do not guarantee regulatory approval. You should not rely too much on these statements.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in these statements, including without limitation, unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies; occurrence of adverse safety events; the risk of unexpected costs or delays; the risk of other unforeseen obstacles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further study, or may fail or decline to approve or delay approval of Biogen’s drug candidates, including lecanemab; the actual timing and content of submissions to and decisions made by regulatory authorities regarding lecanemab; the uncertainty of success in the development and potential commercialization of lecanemab; Failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties related to intellectual property claims and challenges; product liability claims; and third party collaboration risks, results of operations and financial condition. It describes many, but not all, factors that could cause actual results to differ materially from Biogen’s expectations in any statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly reports and in other reports Biogen has filed with the USSecurities and Exchange Commission. These statements were made only as of the date of this news release. Biogen undertakes no obligation to publicly update any forward-looking statements.
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