4 days ago · Please see full Prescribing Information for LEQEMBI, including Boxed WARNING. Notes to Editors. 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 ...

Jan 14, 2025 · The US FDA accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly LEQEMBI IV maintenance dosing in June 2024 and set a PDUFA action date for January 25, 2025. Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product ...

Jun 10, 2024 · LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).

Jan 9, 2024 · LEQEMBI (lecanemab) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

3 days ago · Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his ...

eisai's approach to u.s. pricing for leqembi™ (lecanemab), a treatment for early alzheimer's disease, sets forth our concept of "societal value of medicine" in relation to "price of medicine" Read more >

3 days ago · Stockholm, January 27, 2025 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has approved BioArctic’s partner Eisai’s Supplemental Biologics License Application (sBLA) for Leqembi as a once every four weeks intravenous (IV) maintenance dosing. Leqembi is indicated for the treatment of Alzheimer’s disease in patients with ...

3 days ago · Eisai logo (PRNewsfoto/Eisai Inc.) The sBLA is based on modeling of observed data from the Phase 2 study (Study 201) and its long-term extension (LTE) as well as the Clarity AD study (Study 301 ...

Jan 13, 2025 · The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data. If LEQEMBI subcutaneous maintenance dosing is approved by the FDA, LEQEMBI will be the only treatment for AD that can be administered subcutaneously at home using an autoinjector (AI).

Oct 31, 2024 · Eisai and Biogen await FDA approval, which would allow at-home use of the LEQEMBI autoinjector, making treatment easier for early AD patients and their caregivers.