Eisai Co., Ltd. and Biogen Inc. announced today that the Therapeutic Goods Administration (TGA) of Australia issued a public statement about the initial decision not to register the humanized anti-solubleaggregated amyloid-beta (Aβ) monoclonal antibody lecanemab for the treatment of patients with mild cognitive impairment (MCI)due to Alzheimer’s disease (AD) and mild AD dementia.
Eisai will request a reconsideration of this decision under Section 60* of the Therapeutic Goods Act within 90 days to make lecanemab available for eligible people living with early AD in Australia. Following Eisai’s request for review, the TGA will issue a final decision within 60 days of receiving Eisai’s request.
Lecanemab is already approved in the United States, Japan, China, South Korea, Hong Kong, Israel UAE and Great Britain, and is being marketed in the U.S., Japan and China.
Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision- making authority.
*When we receive the outcome of the evaluation, Section 60 of the Australian legislation defines this as an “initial decision”. This is because the legislation states any decision considered an “initial decision” can be reviewed on request. This legislated process is referred to as a“request for a review of an initial decision” by the TGA. Note the specific part of the legislation that defines this is Section 60 of the Therapeutic Goods Act.
About lecanemab (Leqembi®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).
Lecanemab is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE and Great Britain for the treatment of MCI due to AD and mild AD dementia. Lecanemab’s approvals in these countries were primarily 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 statisticallysignificant results. 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.
Lecanemab is marketed in the U.S., Japan and China. Eisai has also submitted applications for approval of lecanemab in 10 countries and regions, including the European Union.
Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normaland 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.
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. Eisaiserves 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.
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 theantibody back-up was signed in May 2015.
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. The website and social media channels are intended
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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.
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