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LEQEMBI® (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Australia
TOKYO and CAMBRIDGE, Mass., Sept. 24, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Therapeutic Goods Administration (TGA) of Australia has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name, generic name: lecanemab) for mild cognitive impairment (MCI
About this update from Biogen Inc.
[{"type":"image","alt":"Biogen Inc.","displaySize":"","headline":null,"caption":"Biogen Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":101,"url":"https://media.zenfs.com/en/globenewswire.com/d780d0e9a7ba00777730acf271f9e937"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/wH5zYbm3mC0cXQRHhCXgVw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE0MTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/d780d0e9a7ba00777730acf271f9e937","width":300,"height":101}},"lazy":false},{"type":"text","content":"TOKYO and CAMBRIDGE, Mass., Sept. 24, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Therapeutic Goods Administration (TGA) of Australia has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name, generic name: lecanemab) for mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD) (collectively referred to as early AD) in adults who are either ApoEε4* non-carriers or heterozygous carriers.","length":665,"tagName":"p"},{"type":"text","content":"In response to February 2025 TGA decision not to approve lecanemab as a treatment for people with early AD, in March 2025, Eisai requested a review by the Administrative Review Tribunal. As a result of discussions during this process, the TGA and Eisai reached an agreement that led to the approval of LEQEMBI.","length":310,"tagName":"p"},{"type":"text","content":"In Australia, the number of people living with dementia was estimated to be approximately 425,000 in 2024, and is reported to increase to nearly 1,100,000 by 2065.1 AD is considered the most common cause of dementia, typically accounting for 60-70% of cases.2 AD is a progressive, relentless disease with amyloid beta (Aβ) and tau as hallmarks that is caused by a continuous underlying neurotoxic process that begins before amyloid plaque removal and continues afterward.3,4,5 Only LEQEMBI fights AD in two ways – targeting both the toxic protofibrils** and amyloid plaque 2, which can impact tau downstream.","length":608,"tagName":"p"},{"type":"text","content":"Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and B...