Australia's Therapeutic Goods Administration Rejects Lecanemab for Early Alzheimer's Treatment

Therapeutic Goods Administration Rejects Lecanemab

In a significant blow to the fight against Alzheimer's disease, the Therapeutic Goods Administration (TGA) of Australia has decided not to register Lecanemab, a treatment for early-stage Alzheimer's disease. This decision impacts both patients and their caregivers, who were hopeful for a new therapy that could potentially alter the course of this debilitating condition.

Lecanemab, developed by BioArctic AB in collaboration with Eisai, was designed to target the underlying causes of Alzheimer's. It aimed to treat mild cognitive impairment attributed to Alzheimer's disease and mild Alzheimer's dementia. The drug has gained approval in several other regions, such as the U.S., Japan, and parts of Europe, thus raising expectations for its acceptance in Australia.

The TGA's initial rejection came in October 2024, and since then, Eisai has sought a reassessment of this decision. Initially, Eisai proposed a broader indication for treatment based on criteria accepted by regulatory agencies in other major markets, including the U.K. and Europe. However, the TGA proposed a much narrower indication, focusing only on specific groups of patients, particularly ApoE4 noncarriers, because of potential risks associated with certain genetic profiles.

Despite these setbacks, Eisai remains committed to ensuring that eligible patients receive access to Lecanemab. The company indicated that they might consider an appeal to the Administrative Review Tribunal to reassess the TGA's decision. Gunilla Osswald, CEO of BioArctic, expressed immense disappointment regarding the TGA’s conclusion, stating that it represents a setback for patients who urgently need access to effective treatments for Alzheimer's disease. She articulated the distressing reality that time is of the essence for such patients and emphasized the need for a treatment option that could delay the progression of the disease.

Alzheimer's disease is the most prevalent cause of dementia, expected to affect approximately 849,000 people in Australia by 2058. Current statistics show that about 411,000 Australians were diagnosed with dementia in 2023, underscoring the urgent need for novel treatments that can alter the disease's trajectory.

Lecanemab works by targeting both soluble and insoluble forms of amyloid-beta, believed to play a crucial role in the onset and progression of Alzheimer’s disease. This dual mechanism of action allows the drug to significantly reduce the aggregation of amyloid plaques, which are hallmarks of the disease, and has been shown to slow cognitive and functional decline in patients.

For patients with early Alzheimer's, access to treatments like Lecanemab represents hope. With Alzheimer's disease generally progressing in stages, each presenting unique challenges, the delay or denial of effective treatment can have profound implications for both patients and their support systems. Eisai's ongoing commitment to finding a solution for Australian patients reflects an understanding of this urgency.

Aside from Australia's rejection, Lecanemab has been validated in 11 other markets worldwide. The European Union’s Committee for Medicinal Products for Human Use has reaffirmed its positive stance regarding the treatment, signaling a continuation of Lecanemab’s journey towards regulatory acceptance in various regions.

The story of Lecanemab is part of a decades-long collaboration between BioArctic and Eisai, stemming from pioneering laboratory work linked to genetic mutations associated with Alzheimer’s disease. As the situation unfolds, stakeholders remain hopeful that pathways can be found to bring Lecanemab to the Australian market, ensuring that it reaches those who need it most.

As the healthcare community and industry observers await further developments in this matter, it is clear that the TGA's decision has caused a ripple effect that will influence many lives in Australia. Advocacy for early Alzheimer’s treatments like Lecanemab remains strong, emphasizing the critical need for innovations that can make substantial differences in patient outcomes and quality of life.