Therapeutic Goods Administration Of Australia Rejects Eisai And Biogens’ Lecanemab For Early Alzheimer’s, Mentioning Safety Concerns

Eisai Co., Ltd. and Biogen Inc. announced that Australia’s Therapeutic Goods Administration (TGA) has maintained its initial decision to decline approval for lecanemab, an anti-amyloid-beta monoclonal antibody, as a treatment for early Alzheimer’s disease (AD). Despite Eisai’s request for reconsideration, which proposed an indication for ApoE4 noncarriers and heterozygotes similar to approvals in the EU and UK, the TGA limited its alternative proposal only to noncarriers, citing safety concerns for heterozygotes. Eisai suggested a compromise where heterozygotes would receive treatment under specialist supervision, but this proposal was also rejected.

Lynn Kramer, M.D., Chief Clinical Officer at Eisai, said in a statement, “We are extremely disappointed and surprised by the TGA’s decision and understand that the AD community in Australia may also feel disheartened, especially given that eleven countries and regions across the globe have granted marketing authorization. We tried earnestly to reach a compromise with the TGA on an indication that would adequately represent the data in the application but were unfortunately unsuccessful at this time. The TGA proposed a narrow indication that would limit access to only ApoE4 noncarriers. 

He also mentioned, “This indication would deny approximately two-thirds (~70%) of all potentially eligible patients access to a treatment that could slow the progression of AD. Eisai believes ApoE4 heterozygote carriers should at least also have access to lecanemab given the similar benefit-risk profile to the noncarrier population. Therefore, we could not accept this restrictive indication as it is not patient-centric. Given this outcome, we are deeply concerned that Australians living with Alzheimer’s disease will not have access to a treatment that slows the progression of early Alzheimer’s disease by targeting its underlying causes. Eisai remains committed to ensuring eligible Australians with early Alzheimer’s disease can access lecanemab and is exploring options to achieve this, including potentially seeking review by the Administrative Review Tribunal.”

Alzheimer’s disease remains a critical health challenge in Australia, with an estimated 411,000 people living with dementia in 2023, projected to double by 2058. As the most common cause of dementia, AD gradually worsens over time, severely impacting patients, families, and caregivers. Lecanemab targets the underlying pathology of AD by clearing toxic amyloid protofibrils and plaques, which contribute to disease progression and cognitive decline. The therapy has been approved in multiple countries, including the U.S., Japan, and the UK, and remains under review in several other regions, including the EU.

Eisai continues to lead global development and regulatory efforts for lecanemab, with Biogen co-commercializing the drug. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) reaffirmed its positive stance on the drug in February 2025, and the European Commission is currently reviewing its approval. As the global need for effective AD treatments grows, Eisai and Biogen remain committed to advancing lecanemab despite regulatory challenges in Australia.