van Dyck, C., et al. Lecanemab in Early Alzheimer's Disease.New England Journal of Medicine. 2023;388:9-21.https://www.nejm.org/doi/full/10.1056/NEJMoa2212948. Eisai presents full results of lecanema...
FDA’s neurology drug director, Teresa Buracchio, stated that the confirmatory study provided evidence of the drug’s safety and efficacy in treating Alzheimer’s disease. However, the prescribing information for Leqembi will include a warning about potential side effects, including brain swelling and...
U.S.: For the treatment of Alzheimer's disease (AD). It should be initiated in patients with mild cognitive impairment or mild dementia stage of disease. See fullUS prescribing informationincluding boxed waring. Japan: For slowing progression of mild cognitive impairment (MCI) and mild dementia...
Please see full U.S.Prescribing Information, including Boxed WARNING. Eisai has also submitted applications for approval of lecanemab in EU, China, Canada, Great Britain, Australia, Switzerland, South Korea, Israel, Singapore, Taiwan, Brazil and Hong Kong. In China and Israel, the appl...
Please see full Prescribing Information for LEQEMBI, including Boxed WARNING. Notes to Editors 1. About lecanemab (LEQEMBI®) Lecanemab is the result of a strategic research alliance between Eisai and ...
Please see LEQEMBI US Prescribing Information.This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the...
Please see full Prescribing Information for LEQEMBI, including Boxed WARNING. MEDIA CONTACTS Eisai Co., Ltd. Public Relations Department TEL: +81 (0)3-3817-5120 Eisai Inc. (U.S.) Julie Edelman 1-862-213-5915 Julie_Edelman@eisai.com ...
Please see full Prescribing Information. 1 Alzheimer’s Association, 2022 Alzheimer's Disease Facts and Figures https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf 2 Alzheimer’s Association, Changing the Trajectory of Alzheimer’s Disease https://www.alz.org/media/documents/...
day-to-day function and biomarkers. It’s beneficial. Full approval is almost a certainty. If donanemab’s similar results hold up to scrutiny (the data are limited to apress release, they’ll be presented in full at the Alzheimer’s Association International Conference in Ju...
Eisai serves as the lead of LEQEMBI development and regulatory submissions globally, with both Eisai and Biogen Inc. (U.S.) co-commercializing and co-promoting the product. Eisai has the final decision-making authority. Please see fullPrescribing Information, includi...