Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) 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 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.

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 U.S., Japan and China.

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

*When we receive the outcome of the evaluation, Section 60 of the Australian legislation defines this as an “initial decision”. This is because the legislation states any decision considered an “initial decision” can be reviewed on request. This legislated process is referred to as a “request for a review of an initial decision” by the TGA. Note the specific part of the legislation that defines this is Section 60 of the Therapeutic Goods Act.