Leqembi® approved in Mexico
BioArctic AB's partner Eisai has received approval from Mexico's COFEPRIS for Leqembi (lecanemab) to treat early Alzheimer's disease. The drug, which selectively binds to amyloid-beta aggregates, is the first approved treatment proven to reduce disease progression and slow cognitive decline through this mechanism.
The approval is supported by successful results from the Phase 3 Clarity AD clinical trial, where Leqembi met its primary and key secondary endpoints. The drug is already approved in multiple countries including the U.S., Japan, China, and others. In Mexico, approximately 1.3 million people suffer from Alzheimer's disease.
Leqembi was developed through collaboration between BioArctic and Eisai, with BioArctic retaining rights to jointly commercialize in the Nordic region pending European approval.
BioArctic AB ha annunciato che il suo partner Eisai ha ricevuto l'approvazione da COFEPRIS in Messico per Leqembi (lecanemab) per il trattamento dell'Alzheimer nelle fasi iniziali. Questo farmaco, che si lega selettivamente agli aggregati di beta-amiloide, è il primo trattamento approvato dimostrato capace di ridurre la progressione della malattia e rallentare il declino cognitivo tramite questo meccanismo.
L'approvazione si basa sui risultati positivi del trial clinico di Fase 3 Clarity AD, dove Leqembi ha raggiunto i suoi obiettivi primari e secondari principali. Il farmaco è già approvato in diversi paesi, tra cui Stati Uniti, Giappone, Cina e altri. In Messico, circa 1,3 milioni di persone soffrono di Alzheimer.
Leqembi è stato sviluppato grazie alla collaborazione tra BioArctic ed Eisai, con BioArctic che mantiene i diritti di commercializzazione congiunta nella regione nordica in attesa dell'approvazione europea.
BioArctic AB ha anunciado que su socio Eisai ha recibido la aprobación de COFEPRIS en México para Leqembi (lecanemab) para tratar la enfermedad de Alzheimer en etapas tempranas. Este medicamento, que se une selectivamente a los agregados de beta-amiloide, es el primer tratamiento aprobado demostrado capaz de reducir la progresión de la enfermedad y ralentizar el deterioro cognitivo a través de este mecanismo.
La aprobación está respaldada por los resultados exitosos del ensayo clínico de Fase 3 Clarity AD, donde Leqembi cumplió con sus objetivos primarios y secundarios clave. El medicamento ya está aprobado en varios países, incluidos EE. UU., Japón, China y otros. En México, aproximadamente 1.3 millones de personas sufren de Alzheimer.
Leqembi fue desarrollado a través de una colaboración entre BioArctic y Eisai, con BioArctic manteniendo los derechos para comercializar conjuntamente en la región nórdica a la espera de la aprobación europea.
BioArctic AB의 파트너인 Eisai가 멕시코의 COFEPRIS로부터 초기 알츠하이머병 치료를 위한 Leqembi (lecanemab)의 승인을 받았습니다. 이 약물은 아밀로이드 베타 집합체에 선택적으로 결합하며, 이 메커니즘을 통해 질병 진행을 감소시키고 인지 저하를 늦추는 것으로 입증된 첫 번째 승인 치료제입니다.
승인은 Leqembi가 주요 및 핵심 2차 목표를 달성한 3상 Clarity AD 임상 시험의 성공적인 결과에 의해 뒷받침됩니다. 이 약물은 이미 미국, 일본, 중국 등 여러 나라에서 승인되었습니다. 멕시코에서는 약 130만 명이 알츠하이머병을 앓고 있습니다.
Leqembi는 BioArctic과 Eisai 간의 협력을 통해 개발되었으며, BioArctic은 유럽의 승인을 기다리며 북유럽 지역에서 공동 상업화할 권리를 보유하고 있습니다.
BioArctic AB a annoncé que son partenaire Eisai a reçu l'approbation de COFEPRIS au Mexique pour Leqembi (lecanemab) afin de traiter la maladie d'Alzheimer à un stade précoce. Ce médicament, qui se lie de manière sélective aux agrégats de bêta-amyloïde, est le premier traitement approuvé prouvant sa capacité à réduire la progression de la maladie et à ralentir le déclin cognitif par ce mécanisme.
L'approbation s'appuie sur les résultats probants de l'essai clinique de Phase 3 Clarity AD, dans lequel Leqembi a atteint ses objectifs principaux et les critères secondaires clés. Le médicament est déjà approuvé dans plusieurs pays, y compris les États-Unis, le Japon, la Chine, et d'autres. Au Mexique, environ 1,3 million de personnes souffrent de la maladie d'Alzheimer.
Leqembi a été développé grâce à une collaboration entre BioArctic et Eisai, avec BioArctic conservant les droits de commercialisation conjointe dans la région nordique en attendant l'approbation européenne.
BioArctic AB hat bekannt gegeben, dass der Partner Eisai von COFEPRIS in Mexiko die Genehmigung für Leqembi (lecanemab) zur Behandlung von frühem Alzheimer erhalten hat. Das Medikament, das selektiv an Amyloid-Beta-Agregate bindet, ist die erste genehmigte Therapie, die erwiesenermaßen das Fortschreiten der Krankheit verlangsamt und den kognitiven Rückgang durch diesen Mechanismus aufhält.
Die Genehmigung stützt sich auf die erfolgreichen Ergebnisse der Phase 3-Studie Clarity AD, in der Leqembi seine primären und wichtigen sekundären Endpunkte erreicht hat. Das Arzneimittel ist bereits in mehreren Ländern genehmigt, darunter die USA, Japan, China und andere. In Mexiko leiden etwa 1,3 Millionen Menschen an Alzheimer.
Leqembi wurde in Zusammenarbeit zwischen BioArctic und Eisai entwickelt, wobei BioArctic die Rechte zur gemeinsamen Vermarktung in der nordischen Region bis zur Genehmigung durch Europa behält.
- Received regulatory approval in Mexico, expanding market presence
- First approved treatment proven to reduce disease progression rate
- Successfully met primary and secondary endpoints in Phase 3 trial
- Access to Mexican market of 1.3 million Alzheimer's patients
- Expanding global presence with approvals in multiple major markets
- None.
Insights
The approval of Leqembi in Mexico represents another significant milestone in BioArctic's global expansion strategy. This marks the ninth major market approval for their groundbreaking Alzheimer's treatment, targeting a substantial market of approximately 1.3 million patients in Mexico alone.
The drug's unique mechanism of action, targeting both soluble and insoluble amyloid-beta aggregates, has demonstrated compelling efficacy in the Phase 3 Clarity AD trial. This positions Leqembi as a first-in-class treatment that not only addresses symptoms but actually slows disease progression. The successful trial results and growing global regulatory acceptance strengthen the drug's commercial potential.
The expansion into Mexico's market could contribute meaningfully to BioArctic's revenue stream through their partnership with Eisai. This approval pattern suggests strong momentum for potential future market authorizations, particularly in Europe where BioArctic has secured rights for Nordic region commercialization.
Leqembi selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils2), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in Alzheimer's disease, 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 and being marketed in the
Leqembi's approval is based on data from the large global Phase 3 Clarity AD clinical trial, in which Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results. It is estimated that in
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. BioArctic has the right to jointly commercialize Leqembi in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
The information was released for public disclosure, through the agency of the contact person below, on December 5, 2024, at 00.30 CET.
For further information, please contact:
Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.com
Phone: +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 the
Eisai has also submitted applications for regulatory approval of lecanemab in 16 other countries and regions, including the European Union. In November 2024, the treatment received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval. A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was submitted to the
Since July 2020 Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, 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 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 under certain conditions 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 Collectively referred to mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia.
2 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.
3 Secretaría de Salud. Enfermedad de Alzheimer, demencia más común que afecta a personas adultas mayores. Oct 2021. https://www.gob.mx/salud/es/articulos/enfermedad-de-alzheimer-demencia-mas-comun-que-afecta-a-personas-adultas-mayores?idiom=e
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