Rolling sBLA initiated to the U.S. FDA for Leqembi庐 Iqlik鈩� (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. Ci貌 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) anunci贸 que su socio Eisai ha comenzado la presentaci贸n progresiva de una Supplemental Biologics License Application (sBLA) ante la FDA para Leqembi Iqlik en autoinyector subcut谩neo como dosis inicial semanal para el tratamiento temprano de la enfermedad de Alzheimer. Esto sigue a la reciente aprobaci贸n en EE. UU. de Leqembi Iqlik para dosificaci贸n de mantenimiento, el 29 de agosto de 2025.
Si se aprueba, Leqembi Iqlik ser铆a el primer tratamiento anti-amiloide que permite inyecci贸n domiciliaria desde el inicio hasta el mantenimiento. El esquema propuesto contempla 500 mg SC (dos inyecciones de 250 mg) semanalmente, como alternativa a la infusi贸n intravenosa quincenal. El autoinyector requiere solo 15 segundos por inyecci贸n y podr铆a disminuir los recursos sanitarios asociados a la administraci贸n IV.
Leqembi, aprobado actualmente en 48 pa铆ses y en revisi贸n en otros 10, act煤a de forma 煤nica contra las placas amiloides y los protofibrilos en el tratamiento del Alzheimer.
BioArctic AB (雮橃姢雼� 鞀ろ啞頇�毽�: BIOA B)電� 韺岉姼雱堨偓 Eisai臧� FDA鞐� 雽�頃� 氤挫檮 靸濍頃欖爜 鞝滍拡 項堦皜 鞁犾箔(sBLA)鞚� 靾滌皑 鞝滌稖鞚� 鞁滌瀾頄堧嫟瓿� 氚滍憸頄堨姷雼堧嫟. 鞚措矆 鞁犾箔鞚� 臁瓣赴 鞎岇笭頃橃澊毹� 旃橂毳� 鞙勴暅 欤缄皠 鞁滌瀾鞖� 頂柬晿 鞛愱皜欤检偓旮� 鞝滍槙鞚� Leqembi Iqlik鞚� 雽�靸侅溂搿� 頃╇媹雼�. 鞚措姅 2025雲� 8鞗� 29鞚� 氙戈淡鞐愳劀 Leqembi Iqlik鞚� 鞙犾鞖旊矔 鞀轨澑鞐� 鞚挫潃 臁办箻鞛呺媹雼�.
鞀轨澑霅� 瓴届毎 Leqembi Iqlik鞚� 齑堦赴攵�韯� 鞙犾鞖旊矔旯岇 臧�鞝曥棎靹� 韴棳頃� 靾� 鞛堧姅 斓滌磮鞚� 頃晞氚�搿滌澊霌� 旃橂鞝�臧� 霅╇媹雼�. 鞝滌晥霅� 韴棳鞖旊矔鞚� 500 mg 頂柬晿韴棳(250 mg 2須� 欤检偓)鞚� 欤缄皠鞙茧 鞁滍枆頃橂┌, 瓴╈＜ 鞝曤Д 欤检偓鞐� 雽�頃� 雽�鞎堨瀰雼堧嫟. 鞛愱皜欤检偓旮半姅 欤检偓雼� 雼 15齑�毵� 頃勳殧頃� IV 韴棳鞐� 霐半ジ 鞚橂 鞛愳洂 攵�雼挫潉 欷勳澕 臧�電レ劚鞚� 鞛堨姷雼堧嫟.
Leqembi電� 順勳灛 48臧滉淡鞐愳劀 鞀轨澑氚涭晿瓿� 於旉皜搿� 10臧滉淡鞐愳劀 鞁偓 欷戩澊氅�, 鞎岇笭頃橃澊毹� 旃橂鞐愳劀 鞎勲皜搿滌澊霌� 頂岆澕韥檧 頂勲韱犿敿敫岆Υ鞚� 氇憪 響滌爜頃橂姅 鞝愳澊 韸轨鞛呺媹雼�.
BioArctic AB (Nasdaq Stockholm: BIOA B) a annonc茅 que son partenaire Eisai a lanc茅 une soumission progressive d'une Supplemental Biologics License Application (sBLA) 脿 la FDA pour Leqembi Iqlik en autoinjecteur sous鈥慶utan茅 en dose hebdomadaire initiale pour le traitement pr茅coce de la maladie d'Alzheimer. Cela fait suite 脿 l'approbation r茅cente de Leqembi Iqlik pour le dosage d'entretien aux 脡tats鈥慤nis le 29 ao没t 2025.
Si elle est approuv茅e, Leqembi Iqlik deviendrait le premier traitement anti鈥慳mylo茂de permettant des injections 脿 domicile depuis l'initiation jusqu'脿 l'entretien. Le sch茅ma propos茅 pr茅voit 500 mg SC (deux injections de 250 mg) chaque semaine, en alternative 脿 l'administration intraveineuse toutes les deux semaines. L'autoinjecteur n茅cessite seulement 15 secondes par injection et pourrait r茅duire les ressources de sant茅 li茅es aux perfusions IV.
Leqembi est actuellement approuv茅 dans 48 pays et en cours d'examen dans 10 autres; il se distingue en ciblant 脿 la fois les plaques amylo茂des 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 f眉r Leqembi Iqlik als subkutanen Autoinjektor mit w枚chentlicher Anfangsdosis eingeleitet hat, zur Behandlung des fr眉hen Alzheimer鈥慘rankheitstadiums. Dies folgt der j眉ngsten US鈥慫ulassung von Leqembi Iqlik f眉r Erhaltungsdosen am 29. August 2025.
Bei Zulassung w眉rde Leqembi Iqlik als erstes Anti鈥慉myloid鈥慣herapeutikum eine Injektion zu Hause vom Beginn bis zur Erhaltungsphase erm枚glichen. Der vorgeschlagene Dosierungsplan sieht 500 mg SC (zwei Injektionen 脿 250 mg) w枚chentlich vor, als Alternative zur zweiw枚chentlichen intraven枚sen Gabe. Der Autoinjektor ben枚tigt nur 15 Sekunden pro Injektion und k枚nnte den mit IV鈥慓aben verbundenen Aufwand im Gesundheitswesen verringern.
Leqembi ist derzeit in 48 L盲ndern zugelassen und wird in 10 weiteren L盲ndern gepr眉ft; es zeichnet sich dadurch aus, dass es sowohl Amyloid鈥慞laques als auch Protofibrillen bei der Alzheimer鈥態ehandlung 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 (A尾) 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听Only Leqembi fights Alzheimer's disease in two ways 鈥� targeting both amyloid plaque and protofibrilsi, which can impact tau downstream.听
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 听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.听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: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/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 .
1听Amin L, Harris DA. A尾 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.
3听Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503.
i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.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 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.2
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