By Fineline Cube 
Japanese pharmaceutical giant Eisai Co., Ltd. (TYO: 4523) and U.S. biopharma Biogen Inc. (NASDAQ: BIIB) announced today that the Australian Therapeutic Goods Administration (TGA) has granted marketing approval for the humanized anti‑soluble aggregated amyloid‑β monoclonal antibody lecanemab (trade name Leqembi). The approval covers adult patients with mild cognitive impairment (MCI) or mild dementia attributable to Alzheimer’s disease (AD) who are either non‑carriers or heterozygous carriers of the apolipoprotein E ε4 (ApoEε4) allele.
Key Points
- Approval Scope – Leqembi is now authorized for early AD patients in Australia, expanding access beyond the U.S. and EU markets.
- Patient Eligibility – Only patients who are non‑carriers or heterozygous carriers of ApoEε4 may receive the drug; homozygous carriers remain excluded.
- Regulatory Path – The decision follows a successful appeal by Eisai to the TGA’s Administrative Review Tribunal after an initial denial in February 2025.
Regulatory Journey
| Stage | Date | Outcome |
|---|---|---|
| Initial TGA Submission | 2024 | Not approved for early AD patients |
| Administrative Review Tribunal Appeal | March 2025 | Eisai’s application reviewed |
| TGA–Eisai Agreement | 2025‑10‑14 | Marketing approval granted |
The TGA’s revised stance came after extensive discussions and a formal agreement between the agency and Eisai, enabling the drug’s entry into the Australian market.
Strategic Implications
- Market Expansion – The approval positions Leqembi as a global option for early AD treatment, bolstering Eisai’s pipeline in neurodegeneration.
- Collaborative Advantage – The partnership with Biogen leverages the U.S. company’s commercialization expertise and global distribution network.
- Patient Access – Early AD patients in Australia can now receive a therapy that may slow disease progression, addressing a critical unmet need.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech