US FDA approves Leqembi庐 IQKLIK 鈩� (lecanemab-irmb) subcutaneous injection for maintenance dosing for the treatment of early Alzheimer's disease
BioArctic AB (Nasdaq Stockholm: BIOA-B) announced that its partner Eisai received FDA approval for LEQEMBI IQKLIK鈩�, a subcutaneous autoinjector version of lecanemab for maintenance treatment of early Alzheimer's disease. The new formulation will launch on October 6, 2025.
After 18 months of initial Leqembi intravenous treatment, patients can either continue with IV infusions every four weeks or switch to the new weekly 360 mg subcutaneous injection. Leqembi uniquely targets both amyloid plaque and protofibrils, potentially impacting tau accumulation. The treatment aims to slow disease progression and maintain therapeutic benefits through continuous maintenance therapy.
BioArctic AB (Nasdaq Stockholm: BIOA-B) ha annunciato che il suo partner Eisai ha ottenuto la approvazione FDA per LEQEMBI IQKLIK鈩�, una versione autoiniettabile sottocutanea del lecanemab per il trattamento di mantenimento dell鈥橝lzheimer nelle fasi iniziali. La nuova formulazione sar脿 lanciata il 6 ottobre 2025.
Dopo 18 mesi di trattamento iniziale con Leqembi per via endovenosa, i pazienti possono continuare con infusioni EV ogni quattro settimane oppure passare alla nuova iniezione sottocutanea settimanale da 360 mg. Leqembi agisce in modo unico sia sulle placche amiloidi sia sui protofibrille, con un potenziale effetto sull鈥檃ccumulo di tau. L鈥檕biettivo del trattamento 猫 rallentare la progressione della malattia e mantenere i benefici terapeutici attraverso una terapia di mantenimento continua.
BioArctic AB (Nasdaq Stockholm: BIOA-B) anunci贸 que su socio Eisai recibi贸 la aprobaci贸n de la FDA para LEQEMBI IQKLIK鈩�, una versi贸n autoinyectable subcut谩nea de lecanemab para el tratamiento de mantenimiento del Alzheimer en etapas tempranas. La nueva formulaci贸n se lanzar谩 el 6 de octubre de 2025.
Tras 18 meses de tratamiento inicial con Leqembi por v铆a intravenosa, los pacientes pueden continuar con infusiones IV cada cuatro semanas o cambiar a la nueva inyecci贸n subcut谩nea semanal de 360 mg. Leqembi act煤a de forma distintiva tanto sobre las placas amiloides como sobre los protofibrilos, con posible impacto en la acumulaci贸n de tau. El tratamiento pretende ralentizar la progresi贸n de la enfermedad y mantener los beneficios terap茅uticos mediante una terapia de mantenimiento continua.
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鞝曤Д欤检偓(IV)搿� 鞁滌瀾頃橂姅 Leqembi 旃橂毳� 18臧涤洈臧� 歆勴枆頃� 頉�, 頇橃瀽電� 4欤茧雼� IV 欤检偓毳� 瓿勳啀 氚涥卑雮� 靸堧鞖� 欤� 1須� 360 mg 頂柬晿 欤检偓搿� 鞝勴櫂頃� 靾� 鞛堨姷雼堧嫟. Leqembi電� 鞎勲皜搿滌澊霌� 頂岆澕韥檧 頂勲韱犿敿敫岆Υ 霊� 氇憪毳� 響滌爜鞙茧 靷检晞 韮�鞖� 於曥爜鞐� 鞓來枼鞚� 欷� 臧�電レ劚鞚� 鞛堨姷雼堧嫟. 鞚� 旃橂電� 歆堧硲 歆勴枆鞚� 電稊瓿� 歆�靻嶌爜鞚� 鞙犾 旃橂毳� 韱淀暣 旃橂 須臣毳� 鞙犾頃橂姅 瓴冹潉 氇╉憸搿� 頃╇媹雼�.
BioArctic AB (Nasdaq Stockholm: BIOA-B) a annonc茅 que son partenaire Eisai a obtenu la validation de la FDA pour LEQEMBI IQKLIK鈩�, une version auto-injectable sous鈥慶utan茅e du lecanemab destin茅e au traitement d鈥檈ntretien de la maladie d鈥橝lzheimer 脿 un stade pr茅coce. La nouvelle formulation sera lanc茅e le 6 octobre 2025.
础辫谤猫蝉 18 mois de traitement initial par Leqembi en perfusion intraveineuse, les patients peuvent soit poursuivre des perfusions IV toutes les quatre semaines, soit passer 脿 la nouvelle injection sous鈥慶utan茅e hebdomadaire de 360 mg. Leqembi cible 脿 la fois les plaques amylo茂des et les protofibrilles, avec un impact potentiel sur l鈥檃ccumulation de tau. Le traitement vise 脿 ralentir la progression de la maladie et 脿 pr茅server les b茅n茅fices th茅rapeutiques gr芒ce 脿 une th茅rapie d鈥檈ntretien continue.
BioArctic AB (Nasdaq Stockholm: BIOA-B) gab bekannt, dass sein Partner Eisai die FDA-Zulassung f眉r LEQEMBI IQKLIK鈩� erhalten hat, eine subkutane Autoinjektor-Variante von Lecanemab zur Erhaltungstherapie bei fr眉hem Alzheimer. Die neue Formulierung wird am 6. Oktober 2025 auf den Markt kommen.
Nach 18 Monaten initialer Leqembi-IV-Behandlung k枚nnen Patienten entweder mit IV-Infusionen alle vier Wochen fortfahren oder auf die neue w枚chentliche subkutane Injektion 脿 360 mg wechseln. Leqembi richtet sich sowohl gegen Amyloidplaques als auch gegen Protofibrillen und k枚nnte somit die Tau-Akkumulation beeinflussen. Ziel der Behandlung ist es, das Fortschreiten der Erkrankung zu verlangsamen und therapeutische Vorteile durch eine kontinuierliche Erhaltungstherapie zu bewahren.
- FDA approval enables at-home administration through autoinjector device
- New subcutaneous formulation reduces healthcare resource requirements compared to IV administration
- Maintenance dosing options provide flexibility for patients between IV and subcutaneous delivery
- Potential to increase treatment capacity for new patients by freeing up infusion resources
- Requires 18 months of IV treatment before switching to subcutaneous maintenance option
- Disease biomarkers re-accumulate if therapy is discontinued, necessitating continuous treatment
Insights
FDA approval of Leqembi subcutaneous injection enhances BioArctic's Alzheimer's treatment offering with more convenient maintenance dosing option.
The FDA approval of LEQEMBI IQKLIK autoinjector represents a significant advancement in Alzheimer's disease treatment options. This subcutaneous formulation allows patients to transition to a weekly 360 mg injection after 18 months of the standard bi-weekly intravenous treatment, or alternatively continue with IV infusions at a reduced frequency of once every four weeks.
This development addresses several critical challenges in Alzheimer's treatment. First, it recognizes the importance of maintenance therapy to prevent re-accumulation of disease biomarkers after initial treatment. When Leqembi therapy stops, patients return to placebo rates of decline, making continued treatment essential for sustained benefits.
The at-home administration capability is particularly valuable for this patient population. Early Alzheimer's patients and their caregivers face significant logistical challenges with regular infusion center visits. The autoinjector's self-administration option reduces this burden substantially.
From a mechanism perspective, Leqembi's dual action against both amyloid plaque and protofibrils with downstream effects on tau accumulation represents a differentiated approach in the Alzheimer's treatment landscape. This dual-targeting mechanism aligns with current understanding of Alzheimer's pathology involving both amyloid and tau proteins.
Healthcare systems will benefit from freed-up infusion center capacity, allowing more new patients to begin treatment while existing patients continue maintenance therapy at home. The October 6, 2025, launch date gives healthcare systems time to prepare for implementation of this new administration option.
The
Alzheimer's disease is a progressive, relentless disease with A尾 and tau as hallmarks. It progresses in stages that increase in severity over time, and each stage of the disease presents different challenges for those living with the disease and their care partners. There is a significant unmet need for new treatment options that slow the progression of Alzheimer's disease from its early stage and reduce the overall burden on people affected by Alzheimer's disease and society. Only Leqembi fights Alzheimer's disease (AD) in two ways - targeting both amyloid plaque and protofibrils[1], which can impact tau accumulation downstream.[2],[3] Due to the re-accumulation of AD biomarkers and a return to a placebo rate of decline after therapy is stopped, maintenance treatment offers patients options to slow the disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer.
"Eisai's continued work to support and simplify patient and healthcare administration and treatment is an important work to help remove potential bottlenecks in healthcare and broaden patient population while supporting a sustainable long-term cost of treatment," says Gunilla Osswald, CEO at BioArctic. 听
From the perspective of patients and care partners, this can provide the ability to use the device at home, a shortening of treatment time and continued treatment without having to visit an infusion centre.听The subcutaneous formulation also has the potential to reduce healthcare resources associated with IV maintenance dosing, such as preparation for infusion and nurse monitoring, while increasing infusion capacity for new eligible patients to begin initiation treatment and streamlining the overall AD treatment pathway.
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.
This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation.听The information was released for public disclosure, through the agency of the contact person below, on August 29, 2025, at 11:55 p.m. CET.
For further information, please contact:听
Oskar Bosson, Vice President Communications and Investor Relations
E-mail:听[email protected]
Telephone: +46 70听410 71 80
About lecanemab (Leqembi庐)
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 (A尾).
Lecanemab is approved in 48 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 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庐 (lecanemab) 鈥� 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鈩� 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 .
听
[1]听Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of A尾, having a primary role in the cognitive decline associated with this progressive, debilitating condition.i 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 A尾 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.ii
[2]听Eisai presents long-term administration data of lecanemab at the Alzheimer's Association International Conference (AAIC) 2024. Available at:
[3]听McDade et al. Lecanemab in patients with early Alzheimer's disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study. Alzheimers Res Ther. 2022 Dec 21;14(1):191. doi: 10.1186/s13195-022-01124-2.
i 听Morris JC. Neurology. 1993;43(11):2412-4.
ii 听Ono K, Tsuji M. Protofibrils of Amyloid-尾 are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.
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FAQ
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