Eisai to discontinue Tazverik sales in Japan amid safety concerns. Eisai Co., Ltd. has announced plans to discontinue the administration and sales of its anticancer agent Tazverik (tazemetostat hydrobromide) in Japan. This decision follows the voluntary withdrawal of the product in the United States and other countries due to safety concerns. The company has been reviewing safety data from clinical trials and postmarketing reports, which revealed multiple cases of secondary hematologic malignancies associated with both combination and monotherapy treatments using tazemetostat. After a comprehensive evaluation, Eisai concluded that the risk of these malignancies necessitates discontinuing the drug in Japan, even under approved conditions of use. Eisai is currently communicating with medical institutions in Japan to ensure the immediate discontinuation of Tazverik for patients currently receiving it and to prevent the initiation of new treatments. The company emphasized its commitment to providing timely and appropriate information to healthcare professionals to minimize confusion or disruption. The SYMPHONY-1 trial, a phase 1b/3 study, is evaluating the efficacy of adding tazemetostat to the standard second-line treatment of rituximab plus lenalidomide (R2 therapy) in patients with relapsed or refractory follicular lymphoma. This trial is being conducted under Ipsen's leadership as a confirmatory trial for the accelerated approval of Tazverik in the United States and China, involving 229 sites across 15 countries. However, no sites in Japan are participating. Tazemetostat, a first-in-class oral small molecule inhibitor targeting EZH2, was developed under a collaboration between Eisai and Epizyme, Inc., an Ipsen company. Eisai holds exclusive development and commercialization rights for the agent in Japan.

Eisai opens global IT hub in India to boost operations. Eisai Co., Ltd. has inaugurated the Eisai Global Capability Centre (EGCC) in Visakhapatnam, India, marking a significant step in the company's long-term IT strategy. The new center, located within the Eisai Knowledge Centre, aims to serve as the company's information technology hub. The opening ceremony featured notable attendees, including Muneo Takahashi, Consul General of Japan in Chennai, Keisuke Naito, Eisai's COO and Chief Growth Officer, Yumiko Aoyagi, First Secretary at the Embassy of Japan in India, and Vijaya Krishnan, IAS District Director of Anakapalli. The establishment of the EGCC is a core initiative of Eisai Group's strategy to integrate external expertise and cutting-edge technologies. The center will insource the design and operation of internal IT services, providing standardized, high-quality services in a secure environment to support Eisai's global operations. Initially, the EGCC will focus on standardizing global IT infrastructure operations. Its scope will gradually expand to include cybersecurity, data and analytics, and operational applications, adapting to business needs. Since 2009, the Eisai Knowledge Centre in Andhra Pradesh has been a core operational hub for global production and process research. The region is currently focused on establishing a "New IT City," aiming to create 300,000 IT jobs by attracting data centers and AI hubs. By establishing the EGCC in this location, Eisai plans to recruit and nurture global IT talent aligned with its "human health care" concept. The company aims to contribute to the local IT ecosystem and economic prosperity through long-term employment and career development opportunities.

Eisai to present new lecanemab data at AD/PD 2026 conference. Eisai Co., Ltd. will present new research on Lecanemab, its therapy for Alzheimer's disease, at the International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders 2026. The conference will take place March 17-21, 2026, in Copenhagen and online. Eisai plans to present six research updates, including three oral presentations and several poster sessions, highlighting real-world data and long-term outcomes associated with lecanemab. Focus on real-world outcomes and long-term data. The upcoming presentations will emphasize real-world clinical evidence and long-term treatment outcomes for patients receiving lecanemab. Key oral presentations will cover: * Safety and effectiveness of lecanemab in APOE4 homozygous patients based on data from the LEADER real-world study * Long-term treatment persistence and patient characteristics among individuals using lecanemab in routine clinical practice in the United States * A genome-wide association study identifying genetic variants linked to cognitive decline in Alzheimer's disease These findings aim to deepen understanding of how anti-amyloid therapies perform outside controlled clinical trials. Additional poster presentations. Four additional studies will be presented as posters at the conference. Highlights include: * 48-month results from the Clarity AD open-label extension study, focusing on patients who are APOE ε4 non-carriers and heterozygotes * Research examining how lecanemab reduces amyloid-beta protofibrils and how these reductions correlate with biomarkers linked to neuronal and synaptic health * Development of a fully automated plasma pTau205 immunoassay, created in collaboration with Sysmex Corporation Poster sessions will be available for viewing March 17-19 (CET). Industry symposium on early Alzheimer's intervention. Eisai will also host a sponsored symposium titled: "Continue Life Their Way: Early Intervention in Alzheimer's Disease." The session will feature global experts discussing several key topics: * Why early intervention is critical in Alzheimer's disease * Long-term evidence supporting continued treatment in early disease stages * How real-world data can guide clinical decision-making The symposium aims to highlight the importance of recognizing Alzheimer's disease as a chronic condition requiring multidisciplinary care. About lecanemab (LEQEMBI). Lecanemab is a humanized monoclonal antibody designed to target amyloid-beta protofibrils, toxic protein aggregates believed to play a key role in Alzheimer's disease progression. By targeting these aggregates, the therapy aims to: * Reduce amyloid buildup in the brain * Limit neuronal damage * Slow cognitive decline The therapy emerged from a long-standing research collaboration between Eisai Co., Ltd. and BioArctic AB. Global approvals and regulatory progress. Lecanemab has already received approval in more than 50 countries and regions, including: * United States * Japan * China * European Union * South Korea * Saudi Arabia Recent regulatory developments include: * U.S. FDA approval of subcutaneous maintenance dosing (August 2025) * Priority Review for a supplemental Biologics License Application, with a decision expected May 24, 2026 * Ongoing regulatory review of a subcutaneous formulation in multiple countries Ongoing clinical research. Several major clinical trials continue to investigate lecanemab's potential. One of the most notable is the AHEAD 3-45 trial, which focuses on individuals with preclinical Alzheimer's disease who have elevated amyloid levels but no cognitive symptoms. The trial is conducted through a public-private partnership involving: * Alzheimer's Clinical Trial Consortium * National Institute on Aging * Eisai Co., Ltd. * Biogen Inc. Another ongoing program is the Tau NexGen study, which investigates treatments for dominantly inherited Alzheimer's disease. Advancing Alzheimer's treatment strategies. The upcoming presentations at AD/PD 2026 reflect growing interest in real-world evidence, biomarker development, and long-term treatment outcomes for Alzheimer's disease therapies. As research continues, therapies like lecanemab may help refine early intervention strategies, potentially improving long-term outcomes for patients living with this progressive neurodegenerative condition. Optimize your trial insights with Clival Database. Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you. Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets. 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