Eisai and Biogen secure TGA nod for Alzheimer’s drug, but questions linger

The Therapeutic Goods Administration (TGA) has registered Leqembi (lecanemab) for the treatment of mild cognitive impairment due to Alzheimer’s disease and early Alzheimer’s disease in APOE4 non-carriers or heterozygotes.

The registration, announced by Eisai Australia and Biogen Australia, marks a turnaround from October 2024, when the TGA declined to include the therapy on the Australian Register of Therapeutic Goods (ARTG). Eisai subsequently requested a reconsideration of the decision in December 2024 under section 60 of the Therapeutic Goods Act 1989.

Clinical trial data submitted demonstrated that Leqembi slowed disease progression in some patient groups compared to placebo. However, this was not shown consistently across all populations originally proposed for treatment, leading the TGA to approve a narrower indication.

Leading geriatrician and dementia expert, Professor Michael Woodward, said “With more than 812,500 Australians projected to be living with a form of dementia by 2054, there is an urgent need for advances in the early diagnosis and treatment of Alzheimer’s disease.”

Yet questions remain. When Leqembi was withdrawn from the Pharmaceutical Benefits Advisory Committee (PBAC) process last year, the Royal Australian and New Zealand College of Psychiatrists (RANZCP) noted that “the advantages of Leqembi are limited as its effectiveness is less than that of cholinesterase inhibitors for mild to moderate dementia, with current subsidised medications delivering a modest effect.” The College urged careful management of family and carer expectations given the significant resourcing demands, potential side effects including brain swelling and bleeds, and the limited access to PET scans and MRI – particularly in rural and remote communities – which could pose financial barriers for patients.

For advocacy organisations, however, the approval offers fresh hope. Cathy Roth OAM, Chairman of Professionals with Alzheimer’s (PALZ) Global, welcomed the development.

“The impact of Alzheimer’s disease on Australians living with this disease, their families and carers is profound. These Australians experience stigma, fear, and symptoms that affect their quality of life,” said Roth. “Increased early detection, research, and new treatment options for early Alzheimer’s disease are all crucial to give Australians living with this disease, as well as those who sadly may face this diagnosis later in life, new opportunities to manage the progression of the disease.”

Professor Woodward cautioned that system readiness will be critical. “It’s an exciting time but there is work to be done in recalibrating the health system, its resources and focus to fully integrate these therapeutic advances into the effective management of early Alzheimer’s disease,” he said.

Industry leaders reinforced the broader significance. Dr John Bower, Market Access and Medical Director at Eisai in Australia, said “Australians living with Alzheimer’s disease deserve to live their lives in whatever way is most meaningful and fulfilling to them. The TGA registration of this new medicine provides Australians living with early Alzheimer’s disease with a treatment option.”

Monique Alves, Head of Medical Australia and New Zealand at Biogen Australia, added, “This announcement is evidence of that and signals a significant step forward to better supporting Australians, their families and carers who are impacted by this disease.”

More than 400,000 Australians are currently living with dementia, with over 60% estimated to have Alzheimer’s disease. Leqembi is a monoclonal antibody administered via a one-hour intravenous infusion every two weeks in specialised centres.

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