Leqembi® Receives Approval for Early Alzheimer's Treatment in Australia
On September 24, 2025, BioArctic AB (publ), which trades on Nasdaq Stockholm under the ticker BIOA B, announced that Australia’s Therapeutic Goods Administration (TGA) has granted approval for lecanemab, marketed as Leqembi, intended for treating early Alzheimer's disease in adult patients. This approval is particularly focused on individuals who present with mild cognitive impairment or mild dementia and do not carry the apolipoprotein E ε4 (ApoE ε4) allele or are heterozygotes, confirming the presence of amyloid pathology in their systems.
This decision comes after the TGA initially declined to approve lecanemab for early Alzheimer's treatment back in February 2025. Following this, Eisai, a partner in the development of Leqembi, requested a review by the Administrative Review Tribunal. Enhanced discussions led the TGA and Eisai to reach a consensus resulting in the eventual approval, demonstrating a commitment to advancing treatment options for dementia.
Leqembi is the culmination of years of collaboration between BioArctic and Eisai. The development process was significantly influenced by Professor Lars Lannfelt's discovery of a unique Arctic mutation associated with Alzheimer's disease. While Eisai oversees clinical development and commercialization efforts globally, BioArctic retains commercialization rights for the Nordic countries. Together, they are poised to get into the market, ready to make a meaningful impact in treating early Alzheimer's disease in that region.
Currently, Leqembi is already approved in 50 countries, including major markets such as the United States, Japan, China, and member states of the European Union. It is also undergoing regulatory reviews in eight additional countries. In the U.S., Leqembi Iqlik™ has been authorized for subcutaneous injections aimed at ongoing maintenance treatment of early Alzheimer’s disease, representing a crucial step towards patient care.
The ongoing research surrounding lecanemab is highly promising. Since July 2020, Eisai’s Phase 3 clinical study, known as AHEAD 3-45, investigates the effects of lecanemab in individuals who demonstrate signs of preclinical Alzheimer's disease without noticeable symptoms but show intermediate or elevated amyloid levels in their brains. As of October 2024, this important study was fully recruited. This four-year research initiative, formed through a public-private partnership involving Biogen and the Alzheimer's Clinical Trial Consortium, is financially supported by the National Institute on Aging under the National Institutes of Health.
Moreover, the Tau NexGen clinical study, focused on Dominantly Inherited Alzheimer's Disease (DIAD), commenced in January 2022 and incorporates lecanemab in its regimen as a leading anti-amyloid therapy.
BioArctic's long-standing partnership with Eisai, which dates back to 2005, focuses on Alzheimer’s disease treatment development. Their notable agreements include the 2007 development and commercialization agreement centered on the lecanemab antibody and a subsequent 2015 agreement for a backup antibody specifically for Alzheimer's disease. Financially, BioArctic has strategically safeguarded itself from lecanemab's development costs, which entitles it to various sales milestone payments and royalties on global sales.
BioArctic AB positions itself as a pioneering biopharmaceutical firm in Sweden, dedicated to innovative solutions capable of delaying or halting the progression of neurodegenerative conditions. The introduction of Leqembi is a landmark achievement, representing the world's first therapy proven to decelerate the advancement of Alzheimer's disease and mitigate cognitive decline during its early stages. Alongside Leqembi, the organization boasts an extensive research portfolio that includes treatments for Parkinson’s disease and ALS, as well as ongoing projects targeting Alzheimer’s disease.
Employing proprietary technologies such as the BrainTransporter™, which facilitates the targeted transportation of antibodies across the blood-brain barrier, BioArctic seeks to refine the efficacy of neurodegenerative disease treatments further.
For additional information on BioArctic and its innovative contributions to healthcare, please visit www.bioarctic.com.
This decision comes after the TGA initially declined to approve lecanemab for early Alzheimer's treatment back in February 2025. Following this, Eisai, a partner in the development of Leqembi, requested a review by the Administrative Review Tribunal. Enhanced discussions led the TGA and Eisai to reach a consensus resulting in the eventual approval, demonstrating a commitment to advancing treatment options for dementia.
Leqembi is the culmination of years of collaboration between BioArctic and Eisai. The development process was significantly influenced by Professor Lars Lannfelt's discovery of a unique Arctic mutation associated with Alzheimer's disease. While Eisai oversees clinical development and commercialization efforts globally, BioArctic retains commercialization rights for the Nordic countries. Together, they are poised to get into the market, ready to make a meaningful impact in treating early Alzheimer's disease in that region.
Currently, Leqembi is already approved in 50 countries, including major markets such as the United States, Japan, China, and member states of the European Union. It is also undergoing regulatory reviews in eight additional countries. In the U.S., Leqembi Iqlik™ has been authorized for subcutaneous injections aimed at ongoing maintenance treatment of early Alzheimer’s disease, representing a crucial step towards patient care.
The ongoing research surrounding lecanemab is highly promising. Since July 2020, Eisai’s Phase 3 clinical study, known as AHEAD 3-45, investigates the effects of lecanemab in individuals who demonstrate signs of preclinical Alzheimer's disease without noticeable symptoms but show intermediate or elevated amyloid levels in their brains. As of October 2024, this important study was fully recruited. This four-year research initiative, formed through a public-private partnership involving Biogen and the Alzheimer's Clinical Trial Consortium, is financially supported by the National Institute on Aging under the National Institutes of Health.
Moreover, the Tau NexGen clinical study, focused on Dominantly Inherited Alzheimer's Disease (DIAD), commenced in January 2022 and incorporates lecanemab in its regimen as a leading anti-amyloid therapy.
BioArctic's long-standing partnership with Eisai, which dates back to 2005, focuses on Alzheimer’s disease treatment development. Their notable agreements include the 2007 development and commercialization agreement centered on the lecanemab antibody and a subsequent 2015 agreement for a backup antibody specifically for Alzheimer's disease. Financially, BioArctic has strategically safeguarded itself from lecanemab's development costs, which entitles it to various sales milestone payments and royalties on global sales.
BioArctic AB positions itself as a pioneering biopharmaceutical firm in Sweden, dedicated to innovative solutions capable of delaying or halting the progression of neurodegenerative conditions. The introduction of Leqembi is a landmark achievement, representing the world's first therapy proven to decelerate the advancement of Alzheimer's disease and mitigate cognitive decline during its early stages. Alongside Leqembi, the organization boasts an extensive research portfolio that includes treatments for Parkinson’s disease and ALS, as well as ongoing projects targeting Alzheimer’s disease.
Employing proprietary technologies such as the BrainTransporter™, which facilitates the targeted transportation of antibodies across the blood-brain barrier, BioArctic seeks to refine the efficacy of neurodegenerative disease treatments further.
For additional information on BioArctic and its innovative contributions to healthcare, please visit www.bioarctic.com.
Topics Health）
【About Using Articles】
You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.
【About Links】
Links are free to use.