Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, \u201cEisai\u201d) announced today the presentation of data from the company\u2019s extensive Alzheimer\u2019s disease (AD) pipeline, including six oral presentations that will provide deeper insights into lecanemab\u2019s potential as a treatment for early AD. Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta (A\u03b2) protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway in September 2021. The lecanemab data and additional research findings from Eisai\u2019s robust AD pipeline will be featured in 10 presentations, including five late breaker oral presentations, at the 14th Clinical Trials on Alzheimer\u2019s Disease (CTAD) conference, November 9-12, 2021, in Boston, Massachusetts and virtually.<\/p>\n
\u201cThe findings Eisai will present at CTAD provide scientific insights into the potential role of lecanemab in the treatment of early Alzheimer\u2019s disease as well as the relationship between clearance of amyloid-beta plaque from the brain, changes in blood-based biomarkers and clinical outcomes,\u201d said\u00a0Michael Irizarry, M.D., Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. \u201cWe are working to advance lecanemab and our other targeted investigational compounds as quickly as possible in our commitment to bringing solutions to patients and their families.\u201d<\/p>\n
The focus on AD has historically been on alleviating cognitive, functional, and behavioral symptoms, but there has been significant progress in understanding the biological mechanisms of the disease and Eisai\u2019s investigational pipeline aims to treat the range of underlying pathophysiology, including amyloid, tau and neurodegeneration.<\/p>\n
\u201cWith lecanemab\u2019s rolling BLA submission to the FDA under the accelerated approval pathway, completion of enrollment of 1,795 patients in the confirmatory Phase 3 Clarity AD clinical trial, initiation of a lecanemab subcutaneous dosing Phase 1 study and the ongoing Phase 3 AHEAD 3-45 study in people with pre-clinical Alzheimer\u2019s disease, it is an exciting time for lecanemab and Eisai\u2019s AD franchise,\u201d said Ivan Cheung, Chairman, Eisai Inc., Senior Vice President, President Neurology Business Group and Global Alzheimer\u2019s Disease Officer, Eisai Co., Ltd. \u201cWe are optimistic about the promise lecanemab and other investigational compounds in our robust pipeline may have for people living with Alzheimer\u2019s disease.\u201d<\/p>\n
Major Presentations Provide Deeper Scientific Insights into Lecanemab\u2019s Potential as a Treatment for Early AD<\/b><\/p>\n
\u00b7<\/strong> Roundtable: Presentation of the latest lecanemab data, followed by esteemed faculty, Drs. Jeffrey Cummings, Randall Bateman and Christopher van Dyck, facilitating a conversation about the results and insights useful to the broader AD community (Oral Roundtable 5)<\/p>\n