Alzheimer’s Disease Breakthrough: LEQEMBI Approved in South Korea
Alzheimer’s disease is a tragic condition that impacts numerous individuals worldwide, leading to memory loss, cognitive decline, and confusion. The recent approval of LEQEMBI (lecanemab) in South Korea represents a significant advancement in the fight against this debilitating illness. This innovative therapy brings hope to patients and their families by offering a new treatment option that targets the root cause of Alzheimer’s. In this article, we will delve into the implications of LEQEMBI’s approval in South Korea and its potential impact on the future of Alzheimer’s disease treatment.
LEQEMBI Approval in South Korea
Eisai Co., Ltd. and Biogen Inc. have announced the approval of LEQEMBI by the Ministry of Food and Drug Safety (MFDS) in South Korea. This humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody is now authorized for the treatment of adult patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease. LEQEMBI works by selectively binding to soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are crucial components of Aβ plaques in Alzheimer’s disease. By reducing both Aβ protofibrils and Aβ plaques in the brain, LEQEMBI has shown to slow down the progression of the disease and mitigate cognitive and functional decline. South Korea joins the ranks of the U.S., Japan, and China as the fourth country to approve LEQEMBI.
Impact on Dementia Patients in South Korea
With an estimated 900,000 dementia patients in South Korea in 2021, the approval of LEQEMBI comes as a beacon of hope for those affected by this condition. Statistics show that one in ten individuals over the age of 65 suffer from dementia, while one in five experience mild cognitive impairment. The financial burden of dementia care is also significant, with an average annual cost of 21.1 million KRW per patient, escalating to 33.1 million KRW for severe cases. Eisai’s commitment to early diagnosis and treatment of Alzheimer’s disease underscores the importance of addressing this pressing healthcare issue.
The Science Behind LEQEMBI
Protofibrils, believed to contribute to the brain damage seen in Alzheimer’s disease, are considered the most toxic form of Aβ and play a crucial role in cognitive decline. By reducing protofibrils, LEQEMBI has the potential to prevent cognitive dysfunction and neuronal damage in the brain. Developed through a strategic partnership between Eisai and BioArctic, LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble and insoluble forms of Aβ. Its approval in the U.S., Japan, and China underscores its effectiveness in slowing the progression of Alzheimer’s disease.
Clinical Efficacy and Future Developments
Clinical trials have demonstrated LEQEMBI’s efficacy in reducing cognitive decline and improving daily living activities in patients with Alzheimer’s disease. The drug’s approval in additional countries and regions, including the European Union, reflects its global potential in transforming Alzheimer’s treatment. Ongoing research efforts aim to enhance the convenience of LEQEMBI through the development of a subcutaneous injection formulation. Eisai’s collaboration with Biogen and BioArctic highlights the collective effort to advance Alzheimer’s disease therapies and provide better outcomes for patients worldwide.
the approval of LEQEMBI in South Korea represents a significant step forward in the treatment of Alzheimer’s disease. By targeting the underlying mechanisms of the disease, LEQEMBI offers new hope for patients and their families. Continued research and development efforts hold promise for further advancements in Alzheimer’s treatment, bringing us closer to a future where this devastating illness can be effectively managed and potentially cured.At the core of our mission is the commitment to improving the quality of life and promoting healthcare accessibility. This initiative, known as the human healthcare plot, focuses on addressing health concerns and reducing disparities in healthcare access. Through a global network of research and development facilities, manufacturing plants, and marketing branches, we strive to create innovative products to combat diseases with significant unmet medical needs, particularly in the fields of Neurology and Oncology.
Additionally, we demonstrate our dedication to eradicating neglected tropical diseases (NTDs), aligning with Goal 3.3 of the United Nations Sustainable Development Goals (SDGs), by engaging in various initiatives with international partners.
For more information about our organization, please visit our website at www.eisai.com (for global headquarters: Eisai Co., Ltd.) and connect with us on various social media platforms.
About Biogen
Established in 1978, Biogen is a leading biotechnology company dedicated to leveraging cutting-edge science to develop new medicines that can transform patients’ lives and create value for shareholders and communities. By harnessing a deep understanding of human biology and utilizing diverse modalities, we aim to pioneer first-in-class treatments that deliver superior outcomes. Our strategic approach involves taking calculated risks that balance innovation with sustainable growth.
For the latest updates and important information for investors, please visit our website at www.biogen.com. Stay connected with Biogen on popular social media platforms such as Facebook, LinkedIn, X, and YouTube.
References
- Korean dementia observatory 2022: National Institute of Dementia (Korean)
- Korean dementia observatory 2021: National Institute of Dementia (Korean)
- Amin L, Harris DA. Aβ receptors specifically recognize molecular features exhibited 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 Vital Targets of a Disease-Modifying Formulation for Alzheimer’s Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC703770
- LEQEMBI. Prescribing information. Eisai Inc. 2023.
- US Food and Drug Administration. FDA Grants Accelerated Approval of Alzheimer’s Disease Therapy. Available at: https://tinyurl.com/2w7t4y8p. Last accessed: March 2024.
- Eisai Global. 2023. “LEQEMBI® Intravenous Infusion” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Japan. Available at: https://www.eisai.com/news/2023/news202359.html. Last accessed: March 2024.
- Eisai Global. 2024. “LEQEMBI®” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in China. Available at: https://www.eisai.com/news/2024/news202403.html. Last accessed: March 2024.
- van Dyck, H., et al. Lecanemab in Early Alzheimer’s Disease. New England Journal of Medicine. 2023;388:9-21. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948.
MEDIA CONTACTS
Eisai Co., Ltd.
Public Relations Department
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Eisai Inc. (U.S.)
Julie Edelman
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Julie_Edelman@eisai.com
Biogen Safe Harbor
Disclaimer: This news release contains forward-looking statements regarding clinical outcomes of lecanemab, the benefits, safety, and efficacy of LEQEMBI, potential regulatory discussions, submissions and approvals, and the treatment of Alzheimer’s disease. It also addresses the anticipated benefits and potential of Biogen’s collaboration with Eisai, as well as the commercialization of LEQEMBI and potential risks associated with drug development and commercialization. It is important to note that drug development and commercialization entail significant risks, and not all research programs lead to successful product launches. Early-stage clinical results may not accurately predict outcomes from later-stage or larger-scale studies. Investors should exercise caution and consider the risk factors identified in Biogen’s most recent financial reports and filings with the U.S. Securities and Exchange Commission. These forward-looking statements are valid as of the date of this news release, and Biogen does not undertake any obligation to update them.
Source: Eisai
Sectors: BioTech
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