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FDA approves IV maintenance dosing of Leqembi for treatment of early Alzheimer’s in the US
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.
January 27, 2025
Leqembi is indicated for the treatment of Alzheimer’s disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease in the U.S. (early Alzheimer’s disease).
This approval means that patients who have completed the biweekly initiation phase of 18 months have the option to transition to a once every four weeks 10 mg/kg dosing regimen, describes BioArctic in a press release.
Leqembi
Leqembi is already approved in the US, Japan, China, Great Britain and several other markets. In November 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval.
Eisai has submitted applications for approval of lecanemab in 17 countries and regions. Furthermore, the FDA accepted Eisai’s Supplemental Biologics License (BLA) for the Leqembi subcutaneous autoinjector for weekly maintenance dosing in January 2025 and set a PDUFA action date for August 31, 2025, describes BioArctic.
Based on the work of Professor Lars Lannfelt
Leqembi is the result of a collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease.
BioArctic’s lecanemab – one of the world’s best inventions
TIME has selected lecanemab as one of the best inventions of 2023 in the Medical Care category. Lecanemab is based on BioArctic’s founder Professor Lars Lannfelt’s research. It is the first and only fully approved treatment in the US and Japan for patients with mild cognitive impairment or mild Alzheimer’s disease that targets the underlying […]
Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer’s disease. BioArctic has the right to jointly commercialize Leqembi in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
Published: January 27, 2025
