Leqembi® approved for the treatment of early Alzheimer's disease in Australia
BioArctic AB (Nasdaq Stockholm: BIOA B) announced that Australia's Therapeutic Goods Administration (TGA) has approved Leqembi (lecanemab) for treating early Alzheimer's disease. The approval specifically targets adult patients with mild cognitive impairment or mild dementia who are apolipoprotein E ε4 non-carriers or heterozygotes with confirmed amyloid pathology.
This approval follows a review process initiated in March 2025 after an initial rejection in February 2025. Leqembi, developed through collaboration between BioArctic and Eisai, originated from Professor Lars Lannfelt's research on the Arctic mutation in Alzheimer's disease. While Eisai leads global commercialization, BioArctic maintains Nordic region commercialization rights in partnership with Eisai.
BioArctic AB (Nasdaq Stockholm: BIOA B) ha comunicato che la Therapeutic Goods Administration (TGA) australiana ha approvato Leqembi (lecanemab) per il trattamento della fase iniziale della malattia di Alzheimer. L’approvazione riguarda specificamente pazienti adulti con lieve compromissione cognitiva o lieve demenza che non sono portatori o sono eterozigoti per l’apolipoproteina E ε4 e che presentano una patologia amiloide confermata.
Questa approvazione segue un processo di revisione avviato nel marzo 2025 dopo un rifiuto iniziale nel febbraio 2025. Leqembi, sviluppato grazie a una collaborazione tra BioArctic ed Eisai, nasce dalla ricerca del professor Lars Lannfelt sulla mutazione Arctic nella malattia di Alzheimer. Mentre Eisai guida la commercializzazione globale, BioArctic mantiene i diritti di Commercializzazione nella regione nordica in partnership con Eisai.
BioArctic AB (Nasdaq Estocolmo: BIOA B) ha anunciado que la Administración de Alimentos y Medicamentos de Australia (TGA) ha aprobado Leqembi (lecanemab) para tratar la enfermedad de Alzheimer en sus fases tempranas. La aprobación se dirige específicamente a pacientes adultos con deterioro cognitivo leve o demencia leve que no son portadores de ApoE ε4 o que son homocigotos/heterocigotos con patología amiloidea confirmada.
Esta aprobación se produce tras un proceso de revisión iniciado en marzo de 2025, tras una negativa inicial en febrero de 2025. Leqembi, desarrollado mediante la colaboración entre BioArctic y Eisai, se originó a partir de la investigación del profesor Lars Lannfelt sobre la mutación Arctic en la enfermedad de Alzheimer. Aunque Eisai lidera la comercialización global, BioArctic mantiene los derechos de comercialización en la región nórdica en asociación con Eisai.
BioArctic AB (나스닥 스톡홀름: BIOA B)은 호주 의약품청(TGA)이 Leqembi(레카넴맙)를 초기 알츠하이머병 치료제로 승인했다고 발표했다. 이 승인은 경도 인지장애나 경도 치매를 가진 성인 환자 중 APOE ε4 비보유자이거나 확인된 아밀로이드 병리학이 있는 이형접합체 환자에게 특정적으로 적용된다.
이 승인은 2025년 2월의 초기 거절에 이어 2025년 3월에 시작된 심사 절차를 거친 후 이뤄졌다. BioArctic와 Eisai의 협력을 통해 개발된 Leqembi는 알츠하이머병의 Arctic 변이에 대한 연구에서 비롯되었다. Eisai가 글로벌 상용화를 주도하는 한편, BioArctic은 Eisai와의 파트너십으로 북유럽 지역 상용화 권리를 보유한다.
BioArctic AB ( Nass. Stockholm: BIOA B) a annoncé que l’Agence australienne des médicaments (TGA) a approuvé Leqembi (lecanemab) pour le traitement des premières phases de la maladie d’Alzheimer. L’approbation cible spécifiquement les patients adultes présentant un trouble cognitif léger ou une démence légère qui ne portent pas l’allèle APOE ε4 ou qui sont hétérozygotes avec une pathologie amyloïde confirmée.
Cette approbation fait suite à un processus de révision engagé en mars 2025 après un rejet initial en février 2025. Leqembi, développé grâce à une collaboration entre BioArctic et Eisai, est issu des recherches du Professeur Lars Lannfelt sur la mutation Arctic dans la maladie d’Alzheimer. Bien qu’Eisai assure la commercialisation mondiale, BioArctic conserve les droits de commercialisation dans la région nordique en partenariat avec Eisai.
BioArctic AB (Nasdaq Stockholm: BIOA B) gab bekannt, dass die australische Therapeutic Goods Administration (TGA) Leqembi (lecanemab) zur Behandlung der frühen Form der Alzheimer-Krankheit genehmigt hat. Die Genehmigung richtet sich ausdrücklich an erwachsene Patienten mit leichter kognitiver Beeinträchtigung oder leichter Demenz, die keine Träger des ApoE ε4-Allels sind oder heterozygot sind mit bestätigter Amyloidpathologie.
Diese Genehmigung folgt auf einen Überprüfungsprozess, der im März 2025 nach einer anfänglichen Ablehnung im Februar 2025 eingeleitet wurde. Leqembi wurde durch eine Zusammenarbeit zwischen BioArctic und Eisai entwickelt und geht auf die Forschung von Professor Lars Lannfelt zur Arctic-Mutation bei Alzheimer zurück. Während Eisai die weltweite Vermarktung führt, behält BioArctic die Vermarktungsrechte in der nordischen Region in Partnerschaft mit Eisai.
BioArctic AB (ناسدك ستوكهولم: BIOA B) أعلنت أن إدارة الغذاء والدواء الأسترالية (TGA) قد وافقت على Leqembi (lecanemab) لعلاج مرض الزهايمر في مراحله المبكرة. وتستهدف الموافقة بشكل خاص مرضى بالغين لديهم ضعف إدراكي بسيط أو خرف بسيط الذين ليس لديهم ناقلات ApoE ε4 أو الذين هم مغايرون جينيًا من نوع heterozygotes مع وجود بنية أميلويد مؤكدة.
تأتي هذه الموافقة بعد عملية مراجعة بدأت في مارس 2025 عقب رفض أولي في فبراير 2025. Leqembi، الذي طُوّر من خلال تعاون بين BioArctic وEisai، نشأ من أبحاث البروفيسور لارس لانفلت حول طفرة Arctic في مرض الزهايمر. بينما تقود Eisai التسويق العالمي، تحتفظ BioArctic بحقوق التسويق في منطقة الشمال الأوروبي بالشراكة مع Eisai.
BioArctic AB（斯德哥尔摩证券交易所：BIOA B） 宣布澳大利亚药品管理局（TGA）已批准 Leqembi（lecanemab）用于治疗早期阿尔茨海默病。该批准专门针对 成人患者，具轻度认知障碍或轻度痴呆，且为非携带者或等位基因为 ApoE ε4 的异源合子，且具已确认为淀粉样蛋白病变者。
此批准是在2025年3月启动的审查流程之后，于2025年2月的初次被拒后做出的。Leqembi 通过 BioArctic 与 Eisai 的合作开发，源自 Lars Lannfelt 教授关于阿尔茨海默病 Arctic 突变的研究。Eisai 负责全球商业化；BioArctic 与 Eisai 的合作关系使 BioArctic 拥有在北欧地区的商业化权利。
- TGA approval in Australia expands market access for Leqembi
- Successful reversal of initial rejection through review process
- Rights maintained for Nordic region commercialization with Eisai
- Limited approval to specific patient population (ApoE ε4 non-carriers or heterozygotes)
- Initial rejection by TGA indicates potential regulatory challenges
Insights
Leqembi's Australian approval expands market reach for BioArctic's Alzheimer's treatment, boosting commercial potential after initial rejection.
The Australian TGA approval for Leqembi represents a significant regulatory milestone for BioArctic and Eisai in their Alzheimer's disease treatment portfolio. This approval comes after an initial rejection in February 2025, requiring an Administrative Review Tribunal process that ultimately resulted in approval with specific patient population limitations.
The approval is notably restricted to adult patients with mild cognitive impairment or mild dementia due to Alzheimer's disease who are either ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology. This targeted approval approach reflects regulatory caution we're seeing globally with novel Alzheimer's treatments, balancing efficacy against potential side effects in specific genetic populations.
From a regulatory perspective, the successful appeal of the initial rejection demonstrates the companies' commitment to the Australian market and their confidence in addressing regulatory concerns. The approval adds Australia to a growing list of markets where the drug is available, enhancing BioArctic's global commercialization strategy. For context, Leqembi has already received approvals in several major markets including the US, Japan, and others, making this Australian approval another important piece in their global regulatory puzzle.
The collaborative relationship between BioArctic and Eisai appears strategically sound, with clear delineation of responsibilities – Eisai handling broader international development and commercialization while BioArctic maintains Nordic region rights. This approval strengthens their partnership and validates their joint development approach to Alzheimer's treatments.
The approval of Leqembi in Australia represents a meaningful therapeutic advance for early Alzheimer's disease patients in that market. Leqembi (lecanemab) is a monoclonal antibody that targets and removes amyloid plaques in the brain – a hallmark pathology in Alzheimer's disease. The specificity of the approval for ApoE ε4 non-carriers or heterozygotes is clinically significant, as it tailors treatment to genetic populations that may have a more favorable benefit-risk profile.
The drug's mechanism, targeting amyloid beta protofibrils, addresses a fundamental pathological process in Alzheimer's disease. Clinical trials have demonstrated Leqembi can slow cognitive decline by approximately 27% compared to placebo over 18 months in early-stage patients. This modest but measurable benefit must be weighed against potential risks including ARIA (Amyloid-Related Imaging Abnormalities), which include brain edema or microhemorrhages.
The restriction to patients with confirmed amyloid pathology is scientifically sound, ensuring the drug is prescribed to those who actually have the targeted pathology. The exclusion of ApoE ε4 homozygotes likely reflects safety concerns, as this population has shown higher rates of ARIA in clinical studies.
Professor Lars Lannfelt's discovery of the Arctic mutation mentioned in the release was pivotal – this rare genetic variant causes early-onset Alzheimer's by enhancing the formation of soluble amyloid aggregates, which provided crucial insights into disease mechanisms and led directly to Leqembi's development. This approval offers Australian physicians a disease-modifying option beyond purely symptomatic treatments, though the practical impact will depend on reimbursement decisions, healthcare system implementation, and patient monitoring capabilities.
In response to February 2025 the TGA decision not to approve lecanemab for the treatment for people with early AD, in March 2025, Eisai requested a review by the Administrative Review Tribunal. As a result of the discussions during this process, the TGA and Eisai reached an agreement that led to the approval of Leqembi.
Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region.
More information can be found on the Therapeutic Goods Administration (TGA) of
This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person below, on September 24, 2025, at 08:40 a.m. CET.
For further information, please contact:
Oskar Bosson, Vice President Communications and Investor Relations
E-mail: oskar.bosson@bioarctic.com
Telephone: +46 70 410 71 80
About lecanemab (Leqembi®)
Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).
Lecanemab is approved in 50 countries including the
Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with sales milestones as well as royalties on global sales.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) - the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.
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SOURCE BioArctic
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