TGA rejection in stark contrast to global approvals for Alzheimer’s treatment

In a decision that sets Australia apart from the rest of the world, the Therapeutic Goods Administration (TGA) has upheld its initial rejection of Leqembi (lecanemab) for the treatment of Alzheimer’s disease. Eisai Australia and Biogen Australia confirmed that the Minister’s delegate reaffirmed the decision, despite the companies’ appeal under Section 60 of the Therapeutic Goods Act.

This outcome now places Australia in stark contrast to global regulators, as Eisai and Biogen point out that no other country has denied registration to Leqembi. The drug has already been approved in ten countries, including the United States, United Kingdom, Japan, and China, with positive recommendations from the European Medicines Agency for its 27 member states. Meanwhile, evaluations continue in an additional 16 countries, including Switzerland, Canada, Singapore, and India.

The rejection comes as pharmaceutical rival Eli Lilly’s Kisunla (donanemab) edges closer to securing regulatory approval. Eli Lilly’s Medical Services Advisory Committee (MSAC) application is currently seeking Medicare Benefits Schedule (MBS) listings for essential diagnostic tests, including APOE genetic testing, Aß positron emission tomography (PET), and cerebrospinal fluid (CSF) biomarker immunoassays. These tools are critical for confirming Aß pathology and diagnosing mild cognitive impairment or early Alzheimer’s disease, which would be prerequisites for future Pharmaceutical Benefits Scheme (PBS) reimbursement of Kisunla.

Eisai and Biogen expressed deep frustration over the TGA’s stance, emphasising the consequences for Australians living with early Alzheimer’s disease.

“This decision leaves Australians with Early Alzheimer’s disease who may have benefited from the availability of lecanemab, without a TGA-registered option for treatment,” the companies said in a statement.

They also revealed that while the TGA delegate proposed an alternative therapeutic indication, Eisai refused to accept it, arguing that it would unfairly disadvantage patients who could benefit from Leqembi compared to the perceived risks.

With Alzheimer’s disease remaining an irreversible and progressive neurodegenerative condition, Eisai and Biogen continue to stress the urgent need for treatments that target the underlying cause of disease progression.

While acknowledging the complexity of Australia’s regulatory process, Eisai insists it is actively exploring alternative pathways to bring Leqembi to suitable Australian patients. The company said it remains optimistic that the clinical data, which was validated through agreed regulatory endpoints, will ultimately secure approval in Australia.

Eisai and Biogen have been collaborating on the joint development and commercialisation of Alzheimer’s disease treatments since 2014, with both companies co-promoting and co-commercialising Leqembi. However, Australia’s regulatory roadblock now raises critical questions about why Australians are being denied access to a treatment that has been deemed safe and effective by health authorities across the globe.

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