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| Press Releases |
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| Wednesday, September 3, 2025 |
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Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease Under Fast Track Status |
| 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 Eisai has initiated the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI(R)) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting dose after the FDA granted Fast Track Status. more info >> |
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| Monday, September 1, 2025 |
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FDA Approves LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease |
| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI(R) IQLIKTM, pronounced "I Click") for maintenance dosing. more info >> |
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| Friday, August 29, 2025 |
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Ministry Of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Anticancer Agent Tazemetostat for Unresectable INI1-Negative Epithelioid Sarcoma |
| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that it has received orphan drug designation for anticancer agent the EZH2*1 inhibitor tazemetostat hydrobromide (genericname, product name "Tazverik(R) Tablets 200 mg", "tazemetostat") for unresectable INI1*2-negative epithelioid sarcoma that has progressed after chemotherapy, from the Ministry of Health, Labour and Welfare (MHLW). more info >> |
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| Monday, August 25, 2025 |
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Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI(R) (lecanemab) |
| 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 anti-amyloid beta (AB) monoclonal antibody "LEQEMBI(R)" has been launched in Austria on August 25, 2025 and will be launched in Germany on September 1, 2025. more info >> |
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| Monday, August 18, 2025 |
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Eisai Launches In-House Developed Anti-Insomnia Drug DAYVIGO(R) (Lemborexant) in China |
| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the in-house discovered and developed orexin receptor antagonist DAYVIGO(R) (brand name in China: "DAYVIGO(R)" generic name: lemborexant) has launched in China for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. more info >> |
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| Thursday, July 31, 2025 |
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Revenue of LEQEMBI(R) (Preliminary Basis) |
| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the global revenue (pre-audit basis) of the anti-amyloid-beta protofibril antibody "LEQEMBI(R)" (generic name: lecanemab) was JPY 23.1 billion for the first quarter of fiscal year 2025 (April 1, 2025 - June 30, 2025). more info >> |
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Early Alzheimer's Patients Continue to Benefit from Four Years of LEQEMBI(R) (lecanemab-irmb) Therapy New Clinical Data Presented at AAIC
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| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the latest findings demonstrating the benefits of continuous treatment with lecanemab-irmb (U.S. brand name: LEQEMBI(R)), an anti-amyloid beta (AB) protofibril* antibody for the treatment of early Alzheimer's disease (AD), were presented at the Alzheimer's Association International Conference (AAIC) 2025, held in Toronto, Canada, and virtually more info >> |
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New Data Presented at AAIC Demonstrates Investigational LEQEMBI(R) (lecanemab-irmb) 360 mg Subcutaneous Maintenance Dosing Could Offer a New Option for Ongoing Treatment of Early Alzheimer's Disease
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| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai")and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher,"Biogen") announced today that results on investigational maintenance therapy with subcutaneous autoinjector (SCAI) of lecanemab-irmb (U.S. brand name: LEQEMBI(R)), an anti-amyloid beta (AB) protofibril* antibody for the treatment of early Alzheimer's disease (AD), were presented at the Alzheimer's Association International Conference(AAIC) 2025, held in Toronto, and virtually. more info >> |
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Two-Year Real-World Study of LEQEMBI(R) in the United States Presented at Alzheimer's Association International Conference (AAIC) 2025 |
| 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 two-year real-world study in the U.S of lecanemab (generic name, product name: LEQEBMI(R)), an anti-AB protofibril* antibody, was presented at the Alzheimer's Association International Conference (AAIC) 2025, held in Toronto, Canada and virtually more info >> |
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| Tuesday, July 29, 2025 |
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LENVIMA(R) (lenvatinib) in Combination with Pembrolizumab and Transarterial Chemoembolization (TACE) Approved in China for the Treatment of Unresectable, Non-Metastatic Hepatocellular Carcinoma |
| Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that its in-house discovered tyrosine kinase inhibitor, "LENVIMA(R)" (generic name: lenvatinib mesylate), in combination with the anti-PD-1 antibody, pembrolizumab, and transarterial chemoembolization (TACE) has been approved by the National Medical Products Administration (NMPA) of China for unresectable, non-metastatic hepatocellular carcinoma. more info >> |
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| Latest Press Releases |
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Hitachi to deliver the world's first 550 kV gas-insulated switchgear in which the entire equipment is SF(6)-free to Chubu Electric Power Grid
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Eisai Launches Awareness Campaign on Importance of Sleep Through "Pokemon Sleep" Collaboration
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NEC Develops Physical AI That Anticipates Human Movement and Psychological States
Mar 12, 2026 16:41 JST
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More Press release >> |
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