搜尋結果
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) reconfirmed today that the regulatory status for anti-amyloid beta (Aβ) protofibril antibody LEQEMBI® (generic name: lecanemab) subcutaneous (SC) autoinjector, explained at the Financial Disclosure Meeting on August 2, 2024, is as follows.
2023年1月7日 · Using the recently published data from the large global confirmatory Phase 3 clinical trial, Clarity AD, Eisai will work quickly to file a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. INDICATION.
2024年7月31日 · Safety Matters. No new safety findings have been observed with continued lecanemab treatment over three (3) years. Most Amyloid-related imaging abnormalities (ARIA) occurred in the first six months of treatment. After the first six months, ARIA rates are low and similar to ARIA rates on placebo.
2024年1月9日 · LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. China is the third country to grant marketing approval, following the traditional approval in the U.S. in July 2023 and Japanese approval in September 2023.
About lecanemab (LEQEMBI®) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI’s FDA approval was based on Phase 3 data from Eisai’s ...
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (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 and Israel for the ...
On August 15, 1889, in the village of Ito in a mountain gorge in Nyu, Fukui in central Japan, Kikuji Naito and his wife Fuji welcomed their sixth child and third son into the family. The child is Toyoji Naito—a boy who would one day found the Eisai Group. At age 15, Toyoji moved west to Osaka, where his career first began.
