On September 24 2025, Biogen Inc. and Eisai Co. announced that the Australian Therapeutic Goods Administration (TGA) approved LEQEMBI (lecanemab) for the treatment of mild cognitive impairment or mild dementia caused by Alzheimer’s disease in adults who are ApoEε4 non‑carriers or heterozygous carriers.
The approval expands the global launch portfolio of LEQEMBI, adding Australia’s market of approximately 425,000 dementia patients in 2024 and an expected 1.1 million by 2065. The TGA decision follows a review of the drug’s safety and efficacy data and represents a significant regulatory milestone for the product’s early‑AD indication.
Biogen and Eisai will co‑commercialize LEQEMBI in Australia, with Eisai holding final decision‑making authority. The approval strengthens the partnership, provides a new revenue stream in a large aging population, and demonstrates the company’s ability to secure approvals in key international markets.
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