Australia's TGA Denies Lecanemab Registration by BioArctic

BioArctic's Lecanemab Non-Approval by Australia's TGA

BioArctic AB's (publ) (NASDAQ: BIOA) partner Eisai has announced that Australia's Therapeutic Goods Administration (TGA) has opted not to approve lecanemab for the treatment of early Alzheimer's disease (AD). This is a significant blow for both patients and healthcare professionals eager for effective Alzheimer's treatments.

Despite the disappointment, Eisai remains determined to find pathways for Australians to access lecanemab. The company is considering various approaches, including a potential review by the Administrative Review Tribunal to reassess the TGA's decision.

The Decision-Making Process of the TGA

Initially, in October 2024, the TGA decided against registering lecanemab. When Eisai sought a review of this decision in December 2024, they presented an indication aligned with the approvals from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

During the review, the TGA decided on a narrower indication, proposing approval only for patients who are ApoE4 noncarriers, leaving many potential patients without options. Eisai's appeal for a broader indication that includes heterozygotes was also turned down.

Eisai's Efforts and The Impact on Patients

Gunilla Osswald, CEO at BioArctic, expressed deep disappointment regarding the TGA's decision. She voiced concern for the patients and families who will face longer waits for a treatment that could effectively alter the progression of a disease that deeply affects their quality of life.

In Australia, the number of individuals living with dementia is projected to rise significantly, from approximately 411,000 in 2023 to around 849,000 by 2058. Given that Alzheimer's disease is the leading cause of dementia, accounting for 60-70% of cases, the urgency for effective treatment options is paramount.

Understanding Alzheimer's Disease

Alzheimer's is a complex condition characterized by amyloid-beta (A?) aggregation in the brain, which can occur 15 to 20 years prior to the manifestation of symptoms. This disease progresses over time, creating a myriad of challenges for patients and their families. The need for innovative treatments that can slow down the disease's progress is evident.

Lecanemab provides a novel approach to combat AD. Its mechanism works in two significant ways: it clears protofibrils, which are the most toxic form of A?, and it rapidly reduces plaque in the brain. This dual action contributes to the reduction of both cognitive and functional decline in patients.

Global Approval Status of Lecanemab

Notably, lecanemab has already received approvals in 11 markets worldwide, including the U.S., Japan, China, and the United Kingdom. Regulatory applications are pending in the EU and several additional countries. In February 2025, lecanemab received a reaffirmation of its positive opinion from the EU's Committee for Medicinal Products for Human Use, which had previously expressed favorable views.

Collaboration and Future Steps

The development of lecanemab stems from a longstanding partnership between BioArctic and Eisai. The antibody was initially developed by BioArctic, with a focus on countering the effects of Alzheimer's based on groundbreaking research. Eisai manages clinical development and market applications while also preparing for joint commercialization with BioArctic in the Nordic region.

BioArctic boasts a rich portfolio targeting neurodegenerative diseases, working tirelessly to bring new treatments to market. Their collaborative endeavors, particularly around lecanemab, reflect a commitment to addressing the needs of those suffering from Alzheimer's.

Frequently Asked Questions

What was the TGA's decision regarding lecanemab?

The Therapeutic Goods Administration decided not to approve lecanemab for treating early Alzheimer's disease, impacting availability for patients in Australia.

Why did Eisai appeal the TGA's decision?

Eisai sought to have the TGA reconsider its decision in hopes of allowing more patients to access lecanemab, particularly those who might benefit from its use.

What are the future plans for lecanemab?

BioArctic and Eisai are exploring options to appeal the TGA's decision and continue working on global approvals, with lecanemab being available in multiple markets.

How does lecanemab work?

Lecanemab functions by clearing toxic protofibrils and reducing plaque, aiming to decrease cognitive decline in early Alzheimer’s patients.

What is the significance of this denial for Alzheimer's patients?

This decision prolongs the wait for effective treatment options for patients, highlighting a pressing need for innovative solutions in Alzheimer’s care.

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