Rolling sBLA initiated to the U.S. FDA for Leqembi® Iqlik™ (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer's disease under Fast Track status
BioArctic AB (Nasdaq Stockholm: BIOA B) announced that its partner Eisai has initiated a rolling submission of a Supplemental Biologics License Application (sBLA) to the FDA for Leqembi Iqlik's subcutaneous autoinjector as a weekly starting dose for early Alzheimer's disease treatment. This follows the recent approval of Leqembi Iqlik for maintenance dosing in the US on August 29, 2025.
If approved, Leqembi Iqlik would become the first anti-amyloid treatment offering at-home injection from start to maintenance. The proposed dosing regimen includes 500 mg SC dosing (two 250 mg injections) weekly, as an alternative to bi-weekly intravenous dosing. The autoinjector requires only 15 seconds per injection and could potentially reduce healthcare resources associated with IV administration.
Leqembi, currently approved in 48 countries and under review in 10 others, uniquely targets both amyloid plaque and protofibrils in Alzheimer's disease treatment.
BioArctic AB (Nasdaq Stockholm: BIOA B) ha comunicato che il partner Eisai ha avviato una presentazione scorrevole di una Supplemental Biologics License Application (sBLA) alla FDA per Leqembi Iqlik in formulazione sottocutanea con autoiniettore come dose iniziale settimanale per il trattamento precoce della malattia di Alzheimer. Ciò segue la recente approvazione, negli Stati Uniti il 29 agosto 2025, di Leqembi Iqlik per il regime di mantenimento.
In caso di autorizzazione, Leqembi Iqlik diventerebbe il primo trattamento anti-amiloide utilizzabile con iniezione domiciliare fin dall'inizio fino alla fase di mantenimento. Il regime proposto prevede 500 mg per via sottocutanea (due iniezioni da 250 mg) a cadenza settimanale, come alternativa alla somministrazione endovenosa ogni due settimane. L'autoiniettore richiede solo 15 secondi per iniezione e potrebbe ridurre l'impiego di risorse sanitarie legate alle infusioni EV.
Leqembi, attualmente approvato in 48 paesi e in valutazione in altri 10, agisce in modo unico contro sia le placche amiloidi sia i protofibrille nella terapia della malattia di Alzheimer.
BioArctic AB (Nasdaq Stockholm: BIOA B) anunció que su socio Eisai ha comenzado la presentación progresiva de una Supplemental Biologics License Application (sBLA) ante la FDA para Leqembi Iqlik en autoinyector subcutáneo como dosis inicial semanal para el tratamiento temprano de la enfermedad de Alzheimer. Esto sigue a la reciente aprobación en EE. UU. de Leqembi Iqlik para dosificación de mantenimiento, el 29 de agosto de 2025.
Si se aprueba, Leqembi Iqlik sería el primer tratamiento anti-amiloide que permite inyección domiciliaria desde el inicio hasta el mantenimiento. El esquema propuesto contempla 500 mg SC (dos inyecciones de 250 mg) semanalmente, como alternativa a la infusión intravenosa quincenal. El autoinyector requiere solo 15 segundos por inyección y podría disminuir los recursos sanitarios asociados a la administración IV.
Leqembi, aprobado actualmente en 48 países y en revisión en otros 10, actúa de forma única contra las placas amiloides y los protofibrilos en el tratamiento del Alzheimer.
BioArctic AB (나스닥 스톡홀름: BIOA B)는 파트너사 Eisai가 FDA에 대한 보완 생물학적 제품 허가 신청(sBLA)의 순차 제출을 시작했다고 발표했습니다. 이번 신청은 조기 알츠하이머 치료를 위한 주간 시작용 피하 자가주사기 제형의 Leqembi Iqlik을 대상으로 합니다. 이는 2025년 8월 29일 미국에서 Leqembi Iqlik의 유지요법 승인에 이은 조치입니다.
승인될 경우 Leqembi Iqlik은 초기부터 유지요법까지 가정에서 투여할 수 있는 최초의 항아밀로이드 치료제가 됩니다. 제안된 투여요법은 500 mg 피하투여(250 mg 2회 주사)을 주간으로 시행하며, 격주 정맥 주사에 대한 대안입니다. 자가주사기는 주사당 단지 15초만 필요해 IV 투여에 따른 의료 자원 부담을 줄일 가능성이 있습니다.
Leqembi는 현재 48개국에서 승인받았고 추가로 10개국에서 심사 중이며, 알츠하이머 치료에서 아밀로이드 플라크와 프로토피브릴을 모두 표적하는 점이 특징입니다.
BioArctic AB (Nasdaq Stockholm: BIOA B) a annoncé que son partenaire Eisai a lancé une soumission progressive d'une Supplemental Biologics License Application (sBLA) à la FDA pour Leqembi Iqlik en autoinjecteur sous‑cutané en dose hebdomadaire initiale pour le traitement précoce de la maladie d'Alzheimer. Cela fait suite à l'approbation récente de Leqembi Iqlik pour le dosage d'entretien aux États‑Unis le 29 août 2025.
Si elle est approuvée, Leqembi Iqlik deviendrait le premier traitement anti‑amyloïde permettant des injections à domicile depuis l'initiation jusqu'à l'entretien. Le schéma proposé prévoit 500 mg SC (deux injections de 250 mg) chaque semaine, en alternative à l'administration intraveineuse toutes les deux semaines. L'autoinjecteur nécessite seulement 15 secondes par injection et pourrait réduire les ressources de santé liées aux perfusions IV.
Leqembi est actuellement approuvé dans 48 pays et en cours d'examen dans 10 autres; il se distingue en ciblant à la fois les plaques amyloïdes et les protofibrilles dans le traitement de la maladie d'Alzheimer.
BioArctic AB (Nasdaq Stockholm: BIOA B) gab bekannt, dass sein Partner Eisai eine fortlaufende Einreichung einer Supplemental Biologics License Application (sBLA) bei der FDA für Leqembi Iqlik als subkutanen Autoinjektor mit wöchentlicher Anfangsdosis eingeleitet hat, zur Behandlung des frühen Alzheimer‑Krankheitstadiums. Dies folgt der jüngsten US‑Zulassung von Leqembi Iqlik für Erhaltungsdosen am 29. August 2025.
Bei Zulassung würde Leqembi Iqlik als erstes Anti‑Amyloid‑Therapeutikum eine Injektion zu Hause vom Beginn bis zur Erhaltungsphase ermöglichen. Der vorgeschlagene Dosierungsplan sieht 500 mg SC (zwei Injektionen à 250 mg) wöchentlich vor, als Alternative zur zweiwöchentlichen intravenösen Gabe. Der Autoinjektor benötigt nur 15 Sekunden pro Injektion und könnte den mit IV‑Gaben verbundenen Aufwand im Gesundheitswesen verringern.
Leqembi ist derzeit in 48 Ländern zugelassen und wird in 10 weiteren Ländern geprüft; es zeichnet sich dadurch aus, dass es sowohl Amyloid‑Plaques als auch Protofibrillen bei der Alzheimer‑Behandlung adressiert.
- First potential anti-amyloid treatment offering complete at-home injection option from start to maintenance
- Fast Track Status granted by FDA, potentially expediting approval process
- Shorter administration time of only 15 seconds per injection
- Potential reduction in healthcare resources and costs compared to IV administration
- Wide global presence with approval in 48 countries and expanding
- Multiple injections required (two 250 mg injections) for each dose
- Still pending FDA approval for starting dose administration
Insights
Eisai's rolling sBLA for Leqembi subcutaneous starting dose could transform Alzheimer's treatment delivery, potentially increasing accessibility and adoption.
This development represents a potentially significant advancement in Alzheimer's disease treatment administration. Eisai's rolling sBLA submission to the FDA for Leqembi Iqlik as a subcutaneous starting dose follows the recent approval of the same formulation for maintenance dosing on August 29. The FDA's Fast Track designation suggests regulatory recognition of this advancement's potential value.
If approved, Leqembi would become the first anti-amyloid treatment offering complete at-home administration from initiation through maintenance. The autoinjector would allow weekly starting doses via two 250mg injections taking just 15 seconds each, as an alternative to bi-weekly intravenous (IV) infusions currently required during the initiation phase.
This delivery innovation addresses several key challenges in Alzheimer's treatment: it reduces healthcare resource utilization by eliminating infusion preparation and nurse monitoring requirements; improves convenience for patients and caregivers by enabling home administration; and potentially increases treatment accessibility and adherence. The rapid injection time further enhances patient experience.
The dual mechanism targeting both amyloid plaque and protofibrils positions Leqembi uniquely in the market. With approvals in 48 countries and under review in 10 more, this expansion of administration options could significantly strengthen BioArctic and Eisai's market position and treatment adoption rates, particularly as competitors enter this therapeutic space.
In
Alzheimer's disease is a progressive, deadly disease with amyloid beta (Aβ) and tau as hallmarks that is caused by a continuous underlying neurotoxic process that begins before amyloid plaque removal and continues afterward.1,2,3 Only Leqembi fights Alzheimer's disease in two ways – targeting both amyloid plaque and protofibrilsi, which can impact tau downstream.
Leqembi is currently approved in 48 countries and is under regulatory review in 10 countries.
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.
Please see full Prescribing Information for Leqembi in the US, including Boxed WARNING.
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 3, 2025, at 01:30 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 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® (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/articles/market-capitalization-explained" title="Read: What Is Market Capitalization and How It Is Calculated" class="article-link" rel="noopener">Large Cap. For further information, please visit www.bioarctic.com.
1 Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z
2 Ono K, Tsuji M. Protofibrils of Amyloid-β 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.
3 Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503.
i 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.1 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.2
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