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Biogen announces the approval of LEQEMBI® (Lecanemab) for the Treatment of Alzheimer’s Disease
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Australia's Therapeutic Goods Administration (TGA) has approved LEQEMBI® (lecanemab) for the treatment of early Alzheimer's disease (AD) in adults, as announced by Biogen Inc.and Eisai Co., Ltd. This includes those with mild cognitive impairment or mild dementia who are either ApoEε4 non-carriers or heterozygous carriers. This approval follows an earlier TGA decision in February 2025 to not approve the drug, which led to an appeal by Eisai. As a result of discussions, an agreement was reached that led to this approval. The drug is the first to fight AD by targeting both the toxic protofibrils and amyloid plaques. and Eisai Co., Ltd. This includes those with mild cognitive impairment or mild dementia who are either ApoEε4 non-carriers or heterozygous carriers. This approval follows an earlier TGA decision in February 2025 to not approve the drug, which led to an appeal by Eisai. As a result of discussions, an agreement was reached that led to this approval. The drug is the first to fight AD by targeting both the toxic protofibrils and amyloid plaques.

The TGA's decision was primarily based on data from the global Phase 3 Clarity AD clinical trial. This study involved 1,795 patients with early AD, and LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results. In the Australian population specifically, treatment with LEQEMBI reduced clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale by 33% at 18 months compared to placebo. The most frequently reported side effects included infusion-related reactions, headache, and ARIA (Amyloid Related Imaging Abnormalities), a recognized side effect that involves swelling and potential bleeding in the brain.

LEQEMBI is a humanized monoclonal antibody that targets aggregated soluble and insoluble forms of amyloid-beta. Protofibrils, which are believed to be the most toxic form of amyloid-beta, are a primary target of the drug and are considered to have a significant role in the cognitive decline associated with AD. By reducing protofibrils, the drug is believed to prevent the progression of AD and reduce damage to neurons and cognitive dysfunction.

This approval in Australia marks LEQEMBI's approval in 50 countries globally, with regulatory reviews ongoing in eight others. The drug has also seen recent approvals for new formulations in the U.S., including an intravenous (IV) maintenance dose in January 2025 and a subcutaneous maintenance dose in August 2025. Eisai and Biogen have been collaborating on the development of AD treatments since 2014, with Eisai leading the development and regulatory submissions globally and having final decision-making authority. The companies co-commercialize and co-promote the product. Australia has an estimated 425,000 people living with dementia in 2024, a number that is expected to rise significantly by 2065, making the availability of new treatments critically important.

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