LEQEMBI® Intravenous Infusion (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Japan
TOKYO and CAMBRIDGE, Mass., Sept. 25, 2023 (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 humanized anti- soluble aggregated amyloid-beta (Aß) monoclonal antibody LEQEMBI® Intravenous Infusion (200 mg, 500mg, lecanemab) has been approved in Japan as a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD).
LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of Aß. LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline by selectively binding to and eliminating the most toxic Aß aggregates (protofibrils) that contribute to neurotoxicity in AD. In Japan, an application for marketing approval was filed and was designated for priority review in January 2023. Japan is the second country to grant approval, following the traditional approval in the U.S. in July 2023.
LEQEMBI’s approval is based on Phase 3 data from Eisai’s large, global Clarity AD clinical trial, in which LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of LEQEMBI. 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 LEQEMBI reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo. 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. 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 LEQEMBI group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall. Full results of the Clarity AD study were presented at the Clinical Trials on Alzheimer's Disease (CTAD) 2022 conference and simultaneously published in the peer-reviewed medical journal The New England Journal of Medicine on November 29, 2022.
“Today LEQEMBI received approval, making it the first approved anti-amyloid Alzheimer's disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease in Japan. We believe that we have turned a new page in the history of Alzheimer's disease treatment. Alzheimer's disease is a progressive and serious disease that not only causes significant impairment and burden for the people living with it and their care partners, but also has a tremendous impact on society as a whole,” said Haruo Naito, Chief Executive Officer at Eisai. “For around 40 years since we began research on dementia at our Tsukuba Research Laboratories, Eisai has interacted with people with dementia and their care partners, and made efforts to understand their sincere feelings. In response, we have been taking on the challenge to develop therapeutic agents that act on the underlying pathology of Alzheimer's disease. We are committed to delivering LEQEMBI to the people with early Alzheimer's disease who need it and their families as a new treatment that removes the cause of the disease. Through these efforts, we aim to create impact on issues surrounding dementia in Japanese society.”
“With this approval, alongside Eisai, we will be able to help address the devastating impact Alzheimer’s has on people living with the condition as well the emotional, social and financial burden it places on care partners,” said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen. “This is a significant step in the work of Biogen and Eisai to usher in a new era of treatments for this disease which impacts millions. We look forward to working alongside Eisai to build on the approvals in the U.S. and now Japan to bring this option to patients and their families worldwide.”
Eisai will conduct a post-marketing special use results survey (all-case surveillance) in all patients who are administered LEQEMBI until data from a certain number of patients are accumulated after market launch, in accordance with an approval condition imposed by the Ministry of Health, Labour and Welfare. In addition, the appropriate use of LEQEMBI will be promoted in accordance with the package insert and training materials will be developed for healthcare professionals to assist the management and monitoring of amyloid-related imaging abnormalities (ARIA).
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. In Japan, Eisai and Biogen Japan will co-promote LEQEMBI, with Eisai distributing the product as the Marketing Authorization Holder.
*Protofibrils are large Aß aggregated soluble species of 75-5000 Kd.1,2,3.
Notes to Editors
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Incidence of ARIA
ApoE e4 Carrier Status and Risk of ARIA
Concomitant Antithrombotic Medication:
Other Risk Factors for Intracerebral Hemorrhage:
Please see full U.S. Prescribing Information for LEQEMBI, including Boxed WARNING.
2. Product Outline in Japan
2) Generic name
3) Indication for use
4) Dosage and administration
3. About LEQEMBI
Eisai has also submitted applications for approval of lecanemab in EU, China, Canada, Great Britain, Australia, Switzerland, South Korea and Israel. In China and Israel, the applications have been designated for priority review, and in Great Britain, lecanemab has been designated for the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time to market for innovative medicines.
Eisai has completed a lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD (Study 301) open-label extension (OLE). A maintenance dosing regimen has been evaluated as part of Study 201.
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.
4. About the Collaboration between Eisai and Biogen for AD
5. About the Collaboration between Eisai and BioArctic for AD
6. About Eisai Co., Ltd.
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.
7. About Biogen
Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of LEQEMBI; the potential benefits, safety and efficacy of LEQEMBI; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including LEQEMBI; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "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 commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial and AHEAD 3-45 study; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including LEQEMBI; actual timing and content of submissions to and decisions made by the regulatory authorities regarding LEQEMBI; uncertainty of success in the development and potential commercialization of LEQEMBI; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth 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 as well as 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 are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
The Basics: Architecture & Platform Integration
Attention UCaaS Providers: What's Your Teams Strategy?
Generative AI Solutions Showcase Session