Our newest research-advisor Prof. Randall J. Bateman, MD.
Lecanemab Launched in China
Pat & Dennis Bender Early Dementia Diagnosis & Prognosis Fund
J. Dennis Bender
Office, Home & Cell Phone: 859-391-5226
5726 La Jolla Blvd. – Suite 311
La Jolla, CA 92037-7345
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Office - 100 Riverside Pl. - Suite 303
Covington, KY 41011-5711
We support the development of improved diagnostic methods for the early detection and diagnosis of MCI, Alzheimer’s, vascular and other dementias, their likely prognosis, and best treatment options. We focus on the development of Bayesian-based, medical-decision-support systems, comparative-effectiveness research, and the better utilization of these for the above. (After incorporating in KY as a 501(c)3 in 2002, we dissolved that entity in favor of a simplified form of two entirely self-financed, private philanthropies utilizing a Vanguard Charitable Trust for making annual-research-grants for early-dementia-detection and its correct differential-diagnosis and likely-prognosis. They will continue on, after I am long gone, either mentally or physically, with annual grants. Scripps Foundation, Profs. Randall Bateman, James Brewer and others will be our fund’s future research grant advisors. KMK Law is my legal advisor and Elizabeth Dunn is my Estate Administrator & Executor. (See: https://www.alz.org/alzheimers-dementia/research_progress/earlier-diagnosis)
www.JDBender.com – EMS/eVTOL & Educational Experimental Aviation Fund (Vanguard Charitable Trust)
www.JDBender.org – Dementia Diagnosis Fund (Vanguard Charitable Trust)
June 28, 2024
- 乐意保
“Leqembi selectively binds to soluble Aβ-aggregates (protofibrils*), as well as insoluble-Aβ-aggregates (fibrils) which are a major component of Aβ-plaques in AD, thereby reducing both Aβ-protofibrils and Aβ-plaques in the brain. Leqembi is the world’s first and only approved treatment shown to reduce the rate-of-disease-progression and to slow-cognitive-and-functional-decline through this mechanism.”
I too plan to begin treatment with Lecanemab just as soon as I’ve finished cleaning-out my CVG condo and placing it up-for-sale, much as I still love it; but can no longer spend the time commuting back-and-forth annually. Once that is done, I’ll start on Leqembi here in La Jolla. (Fondly remembering our extensive travels in China, Japan, Singapore, and Thailand.) Eisai is distributing the product in China and conducting information provision activities through specialized Medical Representatives, while also working to build a unique early-AD-diagnosis-and-treatment-pathway that combines online and offline services. Early-AD-diagnosis is again the focus of this year’s annual $365,000 investment in research grants to further its development.
Eisai is distributing the product in China and conducting information provision activities through specialized Medical Representatives, while also working to build a unique early-AD-diagnosis-and-treatment-pathway that combines online and offline services. In collaboration with commercial health insurance companies, private health checkups, and nursing homes, Eisai will widely provide disease awareness and pre-screening opportunities and encourage high-risk individuals to visit specialized hospitals early or refer them to "Yin Fa Tong,"** an online health platform for the elderly that is focused on dementia, developed in a joint-venture with JD Health. “Yin Fa Tong” currently has approximately 300,000 registered-users and 6,000 registered-physicians, and introduces information on nearby hospitals and specialists, as well as online medical consultations, and follow-up after Leqembi treatment. Eisai is also working to build evidence for the implementation of definitive diagnosis of early AD using blood-biomarkers, just as we too have been for the past two-plus-decades now.
Eisai is committed to promoting the early detection, diagnosis, and treatment of AD in China, building the dementia ecosystem, and supporting people with early AD to “live their fullest lives”.
I may need to plan another visit back to China to pursue this more directly with them.
“LEQEMBI” (Lecanemab) for the Treatment of Alzheimer’s-Disease Launched in China
China is the Third Country to Launch LEQEMBI Following the United States and Japan
Tokyo and Cambridge, Mass., June 27, 2024 (Globe Newswire)
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “Leqembi” (brand name in China: “乐意保”, generic name: lecanemab) has been launched in China. Leqembi received approval in January 2024 as a treatment of mild-cognitive-impairment (MCI) due to Alzheimer’s-disease (AD) and mild-AD-dementia. China is the third country to launch Leqembi following the United States and Japan.
Leqembi selectively binds to soluble Aβ-aggregates (protofibrils*), as well as insoluble-Aβ-aggregates (fibrils) which are a major component of Aβ-plaques in AD, thereby reducing both Aβ-protofibrils and Aβ-plaques in the brain. Leqembi is the world’s first and only approved treatment shown to reduce the rate-of-disease-progression and to slow-cognitive-and-functional-decline through this mechanism.
Eisai estimates there will be 17-million patients with MCI or mild-dementia-due-to-AD (collectively referred to as early AD) in China in 2024, which is expected to increase as the population ages. Eisai is distributing the product in China and conducting information provision activities through specialized Medical Representatives, while also working to build a unique early-AD-diagnosis-and-treatment-pathway that combines online and offline services. In collaboration with commercial health insurance companies, private health checkups, and nursing homes, Eisai will widely provide disease awareness and pre-screening opportunities and encourage high-risk individuals to visit specialized hospitals early or refer them to "Yin Fa Tong,"** an online health platform for the elderly that is focused on dementia, developed in a joint venture with JD Health. “Yin Fa Tong” currently has approximately 300,000 registered users and 6,000 registered physicians, and introduces information on nearby hospitals and specialists, as well as online medical consultations, and follow-up after Leqembi treatment. Eisai is also working to build evidence for the implementation of definitive diagnosis of early AD using blood biomarkers.
In China, Leqembi will first be launched in the private market. In collaboration with Eisai, a major Chinese medical insurance company has developed and launched a healthcare insurance plan specifically for AD including partial coverage of the drug cost.
Through these efforts, Eisai is committed to promoting the early detection, diagnosis, and treatment of AD in China, building the dementia ecosystem, and supporting people with early AD to “live their fullest lives”.
Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
* 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
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Notes
1. “乐意保”(LEQEMBI) Product Outline Chinese Trade name: “乐意保” (LEQEMBI)
Chinese generic name: 仑卡奈单抗注射液 (lecanemab injection)
Indication for use: Treatment of mild cognitive impairment (MCI) due to Alzheimer’s-disease (AD) and mild AD dementia
Dosage and administration: The usual dose of lecanemab (recombinant) is 10mg/kg infused intravenously over approximately 1 hour, once every 2 weeks.
Active ingredients and strength: 200mg (2mL)/1 vial
Drug price: Lecanemab injection 200mg 2,508 CNY per vial
2. 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).3 Lecanemab is approved in the U.S.,4 Japan,5 China,6 and South Korea.7 In the U.S., Japan, China and South Korea, the indications are as follows:
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LEQEMBI’s FDA approval was based on Phase 3 data from Eisai’s, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results.8 The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with lecanemab reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo.8 The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.21 with lecanemab and 1.66 with placebo (difference, −0.45; 95% confidence interval [CI], −0.67 to −0.23; P<0.001).8 In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by people caring for patients with AD, noted a statistically significant benefit of 37% compared to placebo.8 The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADL score was −3.5 in the lecanemab group and −5.5 in the placebo group (difference, 2.0; 95% CI, 1.2 to 2.8; P<0.001).8 The ADCS MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. 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.8
Eisai has also submitted applications for approval of lecanemab in 14 countries and regions, including the European Union (EU). 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. The rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous injection formulation, which is being developed to enhance convenience for patients, was initiated in the U.S. under Fast Track status in May 2024.
Since 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.
3. About Ying Fa Tong Yin Fa Tong is an online business (Chinese name: 銀髪通) of Jingyi Weixiang (Shanghai) Health Industry Development Limited Company, a joint venture company with Eisai’s Chinese subsidiary Eisai China Holdings Ltd. and JD Health. Yin Fa Tong is a platform that provides community services such as self-checks for cognitive function, and counseling, as well as medical services such as referrals to medical institutions and online consultations, reservations, and medical examinations. For Leqembi, Yin Fa Tong has a dedicated dementia module that allows patients to receive online consultations before a face-to-face appointment, as well as referrals to hospitals where diagnostic tests can be performed before Leqembi administration, notifications regarding the timing of MRI scans, and online consultations during treatment.
4. About the Collaboration between Eisai and Biogen for AD Eisai 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.
5. About the Collaboration between Eisai and BioArctic for AD Since 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.
6. About Eisai Co., Ltd. Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our 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 United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook.
7. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.
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.
- LEQEMBI. Prescribing information. Eisai Inc. 2023.
- US Food and Drug Administration. FDA Grants Accelerated Approval for Alzheimer’s-disease Treatment. Available at: https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment. Last accessed: June 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: June 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: June 2024.
- Eisai Global. 2024. “LEQEMBI” (Lecanemab) Approved for the Treatment of Alzheimer’s-disease in South Korea. Available at: https://www.eisai.com/news/2024/news202436.html. Last accessed June 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.
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