Leqembi approved for the treatment of Alzheimer's disease in the United Arab Emirates
BioArctic AB's partner Eisai announced the approval of Leqembi (lecanemab) for the treatment of Alzheimer's disease in the United Arab Emirates (UAE). The approval is based on the successful Phase 3 Clarity AD study, where Leqembi met its primary and key secondary endpoints. Leqembi is the first approved treatment shown to reduce disease progression and slow cognitive decline by targeting amyloid-beta aggregates in the brain.
In the UAE, 4.09% of those over 60 have dementia, with Alzheimer's being the most common cause. Leqembi is already approved in several countries, including the U.S., Japan, and China. The antibody was originally developed by BioArctic, based on research by Professor Lars Lannfelt. Eisai is responsible for clinical development and commercialization, with Biogen commercializing in the UAE.
BioArctic AB ha annunciato che il suo partner Eisai ha ricevuto l'approvazione per Leqembi (lecanemab) per il trattamento della malattia di Alzheimer negli Emirati Arabi Uniti (EAU). L'approvazione si basa sul successo dello studio di Fase 3 Clarity AD, in cui Leqembi ha raggiunto i suoi obiettivi primari e secondari chiave. Leqembi è il primo trattamento approvato dimostrato per ridurre la progressione della malattia e rallentare il declino cognitivo interagendo con gli aggregati di beta-amiloide nel cervello.
Negli EAU, il 4,09% delle persone sopra i 60 anni ha una forma di demenza, con l'Alzheimer che rappresenta la causa più comune. Leqembi è già approvato in diversi paesi, tra cui gli Stati Uniti, il Giappone e la Cina. L'anticorpo è stato originariamente sviluppato da BioArctic, basato sulla ricerca del professor Lars Lannfelt. Eisai è responsabile dello sviluppo clinico e della commercializzazione, mentre Biogen si occupa della commercializzazione negli EAU.
BioArctic AB anunció que su socio Eisai ha recibido la aprobación de Leqembi (lecanemab) para el tratamiento de la enfermedad de Alzheimer en los Emiratos Árabes Unidos (EAU). La aprobación se basa en el éxito del estudio de Fase 3 Clarity AD, donde Leqembi cumplió con sus objetivos primarios y secundarios clave. Leqembi es el primer tratamiento aprobado que ha demostrado reducir la progresión de la enfermedad y ralentizar el deterioro cognitivo al dirigirse a los agregados de beta-amiloide en el cerebro.
En los EAU, el 4,09% de las personas mayores de 60 años tienen demencia, siendo el Alzheimer la causa más común. Leqembi ya está aprobado en varios países, incluidos Estados Unidos, Japón y China. El anticuerpo fue desarrollado originalmente por BioArctic, basado en la investigación del profesor Lars Lannfelt. Eisai es responsable del desarrollo clínico y la comercialización, mientras que Biogen se encarga de la comercialización en los EAU.
BioArctic AB의 파트너인 Eisai가 아랍에미리트(UAE)에서 알츠하이머병 치료를 위한 Leqembi (lecanemab)의 승인을 발표했습니다. 이번 승인은 Leqembi가 주요 및 주요 2차 목표를 달성한 성공적인 3상 Clarity AD 연구에 기반하고 있습니다. Leqembi는 뇌의 아밀로이드 베타 응집체를 표적으로 하여 질병의 진행을 줄이고 인지 저하를 늦추는 것으로 입증된 최초의 승인된 치료제입니다.
UAE에서는 60세 이상 인구의 4.09%가 치매를 앓고 있으며, 알츠하이머가 가장 흔한 원인입니다. Leqembi는 이미 미국, 일본 및 중국을 포함한 여러 국가에서 승인되었습니다. 이 항체는 BioArctic에 의해 개발되었으며, Lars Lannfelt 교수의 연구를 기반으로 하고 있습니다. Eisai는 임상 개발 및 상업화를 담당하고 있으며, Biogen은 UAE에서 상업화를 담당하고 있습니다.
BioArctic AB a annoncé que son partenaire Eisai a obtenu l'approbation de Leqembi (lecanemab) pour le traitement de la maladie d'Alzheimer aux Émirats Arabes Unis (EAU). Cette approbation est basée sur les résultats positifs de l'étude de Phase 3 Clarity AD, dans laquelle Leqembi a atteint ses principaux objectifs ainsi que des objectifs secondaires clés. Leqembi est le premier traitement approuvé qui a prouvé réduire la progression de la maladie et ralentir le déclin cognitif en ciblant les agrégats d'amyloïdes bêta dans le cerveau.
Aux EAU, 4,09 % des personnes de plus de 60 ans souffrent de démence, l'Alzheimer étant la cause la plus courante. Leqembi est déjà approuvé dans plusieurs pays, y compris les États-Unis, le Japon et la Chine. L'anticorps a été initialement développé par BioArctic, basé sur les recherches du professeur Lars Lannfelt. Eisai est responsable du développement clinique et de la commercialisation, tandis que Biogen s'occupe de la commercialisation aux EAU.
BioArctic AB hat bekannt gegeben, dass ihr Partner Eisai die Genehmigung für Leqembi (lecanemab) zur Behandlung der Alzheimer-Krankheit in den Vereinigten Arabischen Emiraten (VAE) erhalten hat. Die Genehmigung basiert auf der erfolgreichen Phase-3-Studie Clarity AD, in der Leqembi seine primären und wichtigsten sekundären Endpunkte erreicht hat. Leqembi ist die erste zugelassene Behandlung, die nachweislich das Fortschreiten der Krankheit verlangsamt und den kognitiven Abbau durch gezielte Ansprache von Beta-Amyloid-Aggregaten im Gehirn reduziert.
In den VAE haben 4,09% der über 60-Jährigen Demenz, wobei Alzheimer die häufigste Ursache ist. Leqembi ist bereits in mehreren Ländern genehmigt, darunter die USA, Japan und China. Der Antikörper wurde ursprünglich von BioArctic basierend auf der Forschung von Professor Lars Lannfelt entwickelt. Eisai ist für die klinische Entwicklung und Vermarktung verantwortlich, während Biogen in den VAE die Vermarktung übernimmt.
- Leqembi approved for Alzheimer's treatment in UAE, expanding market reach
- Successful Phase 3 Clarity AD study results support approval
- First approved treatment to reduce disease progression and slow cognitive decline in Alzheimer's
- Already approved and marketed in major markets like U.S., Japan, and China
- None.
Insights
This approval of Leqembi in the UAE marks a significant milestone in Alzheimer's disease treatment. The drug's unique mechanism of action, targeting both soluble and insoluble amyloid-beta aggregates, addresses a key pathological hallmark of AD. Its ability to slow cognitive and functional decline offers hope for patients in the early stages of the disease.
The approval based on the Clarity AD study underscores the robustness of the clinical evidence. With
Leqembi's approval in the UAE expands its global footprint, now available in 7 markets including major ones like the US, Japan and China. This strategic expansion could significantly boost Eisai and BioArctic's market presence and revenue potential. The UAE's healthcare market, known for its rapid adoption of innovative treatments, could serve as a gateway for further penetration into the Middle East region.
The collaboration between BioArctic and Eisai, with Biogen's involvement in UAE commercialization, showcases a strong partnership model. This could be advantageous in navigating complex regulatory landscapes and maximizing market reach. Investors should watch for potential approval in Europe, which could trigger BioArctic's commercialization rights in the Nordic region, possibly impacting the company's revenue streams.
Leqembi's approval in the
Leqembi selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils[4]), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in AD, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. Leqembi is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. Leqembi is also approved in the
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 Lecanemab for Alzheimer's disease. Eisai's partner Biogen will commercialize Leqembi in
The information was released for public disclosure, through the agency of the contact persons below, on August 14, 2024, at 01:00 a.m. CET.
For further information, please contact:
Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80
Jiang Millington, Director Corporate Communication and Social Media
E-mail: jiang.millington@bioarctic.se
Phone: +46 79 33 99 166
About lecanemab (generic name, brand name: 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 the
Lecanemab approvals were based on the large global Phase 3 Clarity AD study. In the Clarity AD study, lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.
Eisai has also submitted applications for approval of lecanemab in 11 other countries and regions, including the European Union (EU). A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the
Since July 2020 Eisai's Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD 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 regulatory approvals, and 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.
[1] van Dyck, H., et al. Lecanemab in Early Alzheimer's Disease. New England Journal of Medicine. 2023;388:9-21. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
[2] Qassem T., et al, Prevalence and economic burden of dementia in the Arab world. BJPsych Open. 2023 Jul; 9(4): e126. https://doi.org/
[3] World Health Organization. Dementia Fact Sheet. March 2023. Available at: https://www.who.int/news-room/fact-sheets/detail/dementia.
[4] Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition. Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.
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