Leqembi (lecanemab) authorized for early Alzheimer's disease in Great Britain
BioArctic AB announced that its partner Eisai received Marketing Authorization from the MHRA in Great Britain for Leqembi (lecanemab) to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in specific adult patients. This marks the first authorization in Europe for a medicine targeting an underlying cause of Alzheimer's disease.
Lecanemab selectively binds to and clears toxic Aβ protofibrils from the brain. The approval was based on the Phase 3 Clarity AD clinical trial, which met its primary and key secondary endpoints. Common adverse reactions include infusion-related reactions and amyloid-related imaging abnormalities.
Eisai is working with health authorities to make Leqembi available to eligible patients. The antibody was originally developed by BioArctic, resulting from a collaboration with Eisai.
BioArctic AB ha annunciato che il suo partner Eisai ha ricevuto l'Autorizzazione alla Commercializzazione dalla MHRA nel Regno Unito per Leqembi (lecanemab) per trattare il lieve deterioramento cognitivo e la lieve demenza dovuti alla malattia di Alzheimer in pazienti adulti specifici. Questa rappresenta la prima autorizzazione in Europa per un farmaco che mira a una causa sottostante della malattia di Alzheimer.
Il lecanemab si lega selettivamente e rimuove i protofibrilli Aβ tossici dal cervello. L'approvazione si basa sul trial clinico di Fase 3 Clarity AD, che ha raggiunto i suoi obiettivi primari e secondari chiave. Le reazioni avverse comuni includono reazioni correlate all'infusione e anomalie di imaging correlate all'amiloide.
Eisai sta lavorando con le autorità sanitarie per rendere disponibile Leqembi ai pazienti idonei. L'anticorpo è stato sviluppato originariamente da BioArctic, grazie a una collaborazione con Eisai.
BioArctic AB anunció que su socio Eisai recibió la Autorización de Comercialización de la MHRA en Gran Bretaña para Leqembi (lecanemab) para tratar el deterioro cognitivo leve y la demencia leve por enfermedad de Alzheimer en pacientes adultos específicos. Esto marca la primera autorización en Europa para un medicamento que aborda una causa subyacente de la enfermedad de Alzheimer.
El lecanemab se une selectivamente y elimina los protofibrilos tóxicos de Aβ del cerebro. La aprobación se basó en el ensayo clínico de Fase 3 Clarity AD, que cumplió con sus objetivos primarios y secundarios clave. Las reacciones adversas comunes incluyen reacciones relacionadas con la infusión y anomalías de imagen relacionadas con la amiloide.
Eisai está trabajando con las autoridades de salud para hacer que Leqembi esté disponible para los pacientes elegibles. El anticuerpo fue desarrollado originalmente por BioArctic, como resultado de una colaboración con Eisai.
BioArctic AB는 파트너인 Eisai가 영국의 MHRA로부터 특정 성인을 대상으로 한 알츠하이머병으로 인한 경미한 인지 장애 및 경미한 치매 치료를 위한 Leqembi (lecanemab)에 대한 판매 승인을 받았다고 발표했습니다. 이는 알츠하이머병의 근본 원인을 타겟으로 하는 약물에 대한 유럽에서의 첫 번째 승인을 의미합니다.
Lecanemab는 독성 Aβ 프로토피브릴에 선택적으로 결합하여 뇌에서 이를 제거합니다. 이 승인은 주요 및 주요 2차 목표를 충족한 3상 Clarity AD 임상 시험에 기반하였습니다. 일반적인 부작용으로는 주입 관련 반응과 아밀로이드 관련 영상 이상이 있습니다.
Eisai는 Leqembi를 자격이 있는 환자에게 제공하기 위해 보건 당국과 협력하고 있습니다. 이 항체는 원래 BioArctic에 의해 개발되었으며, Eisai와의 협력으로 탄생했습니다.
BioArctic AB a annoncé que son partenaire Eisai a reçu l'Autorisation de Mise sur le Marché (AMM) de la MHRA au Royaume-Uni pour Leqembi (lecanemab) afin de traiter les troubles cognitifs légers et la démence légère dus à la maladie d'Alzheimer chez des patients adultes spécifiques. Cela représente la première autorisation en Europe pour un médicament ciblant une cause sous-jacente de la maladie d'Alzheimer.
Le lecanemab se lie sélectivement et élimine les protofibrilles Aβ toxiques du cerveau. L'approbation était basée sur l'
Eisai travaille avec les autorités de santé pour rendre Leqembi disponible pour les patients éligibles. L'anticorps a été initialement développé par BioArctic, dans le cadre d'une collaboration avec Eisai.
BioArctic AB gab bekannt, dass ihr Partner Eisai die Marktzulassung von der MHRA in Großbritannien für Leqembi (lecanemab) erhalten hat, um leichte kognitive Beeinträchtigungen und leichte Demenz aufgrund der Alzheimer-Krankheit bei bestimmten erwachsenen Patienten zu behandeln. Dies stellt die erste Zulassung in Europa für ein Medikament dar, das eine zugrunde liegende Ursache der Alzheimer-Krankheit anspricht.
Lecanemab bindet selektiv an und entfernt toxische Aβ-Protofibrillen aus dem Gehirn. Die Genehmigung beruhte auf der Phase-3-Studie Clarity AD, die ihre primären und wichtigen sekundären Endpunkte erreichte. Zu den häufigsten Nebenwirkungen zählen infusionsbedingte Reaktionen und amyloidbezogene Bildabnormalitäten.
Eisai arbeitet mit den Gesundheitsbehörden zusammen, um Leqembi für geeignete Patienten verfügbar zu machen. Der Antikörper wurde ursprünglich von BioArctic entwickelt, das dies in Zusammenarbeit mit Eisai tat.
- First authorization in Europe for a medicine targeting an underlying cause of Alzheimer's disease
- Successful Phase 3 Clarity AD clinical trial results
- Potential to slow the progression of early Alzheimer's disease
- Collaboration with health authorities to make the treatment available
- Common adverse reactions including infusion-related reactions and amyloid-related imaging abnormalities
Insights
The approval of Leqembi (lecanemab) in Great Britain marks a significant milestone in Alzheimer's disease treatment. As the first therapy targeting an underlying cause of the disease approved in Europe, it represents a paradigm shift in management strategies. The drug's mechanism of action, binding to toxic Aβ protofibrils, addresses a key pathological feature of Alzheimer's.
The Clarity AD trial results supporting this approval are promising, showing statistically significant improvements in both primary and secondary endpoints. However, it's important to note the safety profile, particularly the risk of ARIA-H and ARIA-E, which will require careful monitoring in clinical practice.
This approval could potentially benefit a substantial population, given the high prevalence of Alzheimer's in the UK. However, the specific indication for ApoE ε4 heterozygotes or non-carriers in early stages of the disease narrows the eligible patient pool, which is an important consideration for both clinicians and health economists.
The authorization of Leqembi in Great Britain opens up a significant new market for BioArctic and Eisai. With an estimated
The collaboration between BioArctic and Eisai, along with their joint commercialization plans for the Nordic region, positions them well to capitalize on this approval. The next critical step will be pricing and reimbursement negotiations with NICE, SMC and NHS, which will ultimately determine market access and uptake.
Investors should closely monitor these negotiations and initial uptake rates, as they will be key indicators of Leqembi's commercial potential in the European market. The UK approval could also pave the way for broader European acceptance, potentially expanding the drug's market reach significantly.
"The decision from MHRA to authorize lecanemab is an important step forward for eligible patients in
Lecanemab selectively binds to Aβ aggregate species, with preferential activity for toxic Aβ protofibrils[3] (as well as fibrils, which are a major component of Aβ plaques). Lecanemab binds to these aggregate Aβ species to neutralize and clear them from the brain. [4],[5],[6]
The approval was mainly based on Phase 3 data from the global Clarity AD clinical trial, in which the medicine met its primary endpoint and all key secondary endpoints with statistically significant results.[4] In the indicated population in
It is estimated that 982,000 people live with dementia in the
Eisai is working collaboratively with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the National Health Service (NHS) to make this medicine available to eligible people living with early Alzheimer's disease as soon as possible.
Lecanemab 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 serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region and pending European approval Eisai and BioArctic are preparing for a joint commercialization in the region.
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 persons below, on August 22, 2024, at 11.05 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 Communications and Social Media
E-mail: jiang.millington@bioarctic.se
Phone: +46 79 33 99 166
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's approval in
The primary endpoint was the global cognitive and functional scale, CDR-SB.[2] In the Clarity AD clinical trial, treatment with lecanemab, in the indicated population in
In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by people caring for patients with AD, noted
In the indicated population (ApoE ε4 heterozygotes or non-carriers), the most common adverse reactions were infusion-related reaction (
Lecanemab is licensed in the
This medicine is subject to additional monitoring. This will allow quick identification of new safety information.
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.
About NHS, NICE and SMC
The National Health Service (NHS) is a public healthcare system with the principle of providing free medical services to citizens. The National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC) are independent bodies that carry out assessments on the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products regarding their health benefits and price justification as an advisory boards to the National Health Service (NHS) about whether or not a newly licensed drug should be accepted for use under national health insurance.
[1] Apolipoprotein E is a protein involved in the metabolism of fats in humans. It is implicated in Alzheimer's disease.
[2] Lecanemab Great Britain Summary of Product Characteristics
[3] Protofibrils are large Aβ aggregated soluble species of 75-5000 Kda
[4] 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
[5] Johannesson, M., et al. Lecanemab demonstrates highly selective binding to Aβ protofibrils isolated from Alzheimer's disease brains. Molecular and Cellular Neuroscience. 2024;130:103949. https://doi.org/10.1016/j.mcn.2024.103949
[6] Sehlin, D., et al. Large aggregates are the major soluble Aβ species in AD brain fractionated with density gradient ultracentrifugation. PLoS One. 2012;7(2):e32014. https://doi.org/10.1371/journal.pone.0032014
[7] ARIA-H: amyloid-related imaging abnormalities with hemorrhage (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis).
[8] ARIA-E: amyloid-related imaging abnormalities with oedema (edema/effusion).
[9] Alzheimer's Society. 2024. The economic impact of dementia. Available at: https://www.alzheimers.org.uk/about-us/policy-and-influencing/dementia-scale-impact-numbers. Last accessed: August 2024.
[10] World Health Organization. 2023. Dementia. Available at: https://www.who.int/news-room/fact-sheets/detail/dementia. Last accessed: August 2024
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