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Eisai will request reconsideration of initial decision for lecanemab in Australia

BioArctic’s partner Eisai has announced that the Therapeutic Goods Administration (TGA) of Australia issued a public statement about the initial decision not to register the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia.
Eisai will request a reconsideration of this initial decision under Section 60 of the Therapeutic Goods Act within 90 days to make lecanemab available for eligible people living with early AD in Australia. Following Eisai’s request for review, the TGA will issue a final decision within 60 days of receiving Eisai’s request.

CHMP has adopted a negative opinion on BioArctic’s lecanemab for the EU
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated that it has adopted a negative opinion on BioArctic AB’s partner Eisai’s Marketing Authorization Approval (MAA) for lecanemab as treatment for Alzheimer’s disease. Lecanemab is already approved in the United States, Japan, China, South Korea, Hong Kong, and […]
Lecanemab is already approved in the United States, Japan, China, South Korea, Hong Kong, Israel UAE and Great Britain, and is being marketed in the United States, Japan and China.
Lecanemab
Lecanemab 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 discovery of the Arctic mutation in Alzheimer’s disease. Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

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 […]
BioArctic has the right to commercialize lecanemab in the Nordic region and pending European approval Eisai and BioArctic are preparing for a joint commercialization in the region.
Published: October 21, 2024