Eisai Initiated Rolling Supplemental Biologics License Application 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
Eisai and Biogen (NASDAQ:BIIB) have initiated a rolling Supplemental Biologics License Application (sBLA) to the FDA for LEQEMBI IQLIK, a subcutaneous autoinjector formulation of lecanemab-irmb, under Fast Track Status. This new formulation would allow at-home administration of LEQEMBI from the start of treatment for early Alzheimer's disease patients.
The autoinjector would enable a weekly starting dose of 500mg (two 250mg injections) as an alternative to bi-weekly intravenous dosing. Each injection takes approximately 15 seconds to administer. If approved, LEQEMBI IQLIK would be the first anti-amyloid treatment offering at-home injection from initiation through maintenance, potentially reducing healthcare resource utilization.
LEQEMBI is currently approved in 48 countries and under review in 10 others. The drug uniquely targets both amyloid plaque and protofibrils in Alzheimer's disease treatment.
Eisai e Biogen (NASDAQ:BIIB) hanno avviato una sottomissione progressiva di una Supplemental Biologics License Application (sBLA) alla FDA per LEQEMBI IQLIK, una formulazione sottocutanea in autoiniettore di lecanemab-irmb, con status Fast Track. Questa nuova formulazione consentirebbe la somministrazione a domicilio di LEQEMBI fin dall'inizio del trattamento per pazienti con malattia di Alzheimer in fase iniziale.
L'autoiniettore permetterebbe un dosaggio iniziale settimanale di 500 mg (due iniezioni da 250 mg) come alternativa alla somministrazione endovenosa ogni due settimane. Ogni iniezione richiede circa 15 secondi. Se approvato, LEQEMBI IQLIK sarebbe il primo trattamento anti-amiloide che offre l'iniezione domiciliare dall'avvio fino alla terapia di mantenimento, riducendo potenzialmente l'utilizzo delle risorse sanitarie.
LEQEMBI è attualmente approvato in 48 paesi ed è in revisione in altri 10. Il farmaco agisce in modo distintivo contro le placche amiloidi e i protofibrilli nella terapia della malattia di Alzheimer.
Eisai y Biogen (NASDAQ:BIIB) han iniciado una presentación escalonada de una Supplemental Biologics License Application (sBLA) ante la FDA para LEQEMBI IQLIK, una formulación subcutánea en autoinyector de lecanemab-irmb, bajo estatus Fast Track. Esta nueva formulación permitiría la administración en el hogar de LEQEMBI desde el inicio del tratamiento para pacientes con Alzheimer en fase temprana.
El autoinyector permitiría una dosis inicial semanal de 500 mg (dos inyecciones de 250 mg) como alternativa a la dosificación intravenosa cada dos semanas. Cada inyección tarda aproximadamente 15 segundos. Si se aprueba, LEQEMBI IQLIK sería el primer tratamiento antiamiloide que ofrece inyección domiciliaria desde el inicio hasta el mantenimiento, lo que podría reducir el uso de recursos sanitarios.
LEQEMBI está actualmente aprobado en 48 países y en revisión en otros 10. El fármaco actúa de forma única sobre las placas amiloides y los protofibrilos en el tratamiento de la enfermedad de Alzheimer.
Eisai와 Biogen (NASDAQ:BIIB)은(는) Fast Track 지위 하에 레카네맙-irmb의 피하 자가주사기 제형인 LEQEMBI IQLIK에 대해 FDA에 롤링 보충 생물학적 허가신청서(sBLA)를 제출하기 시작했습니다. 이 새로운 제형은 초기 알츠하이머병 환자들의 치료 시작부터 자가(가정) 투여를 가능하게 합니다.
자가주사기는 격주 정맥 투여의 대안으로 초기 주간 용량 500mg(250mg 주사 2회)을 가능하게 합니다. 각 주사는 약 15초가 소요됩니다. 승인되면 LEQEMBI IQLIK은 치료 시작부터 유지요법까지 가정에서 주사할 수 있는 최초의 항아밀로이드 치료제가 되어 의료 자원 사용을 줄일 수 있습니다.
LEQEMBI는 현재 48개국에서 승인되었고 10개국에서 심사 중입니다. 이 약물은 알츠하이머병 치료에서 아밀로이드 플라크와 프로토피브릴을 모두 표적으로 삼는 것이 특징입니다.
Eisai et Biogen (NASDAQ:BIIB) ont lancé un dossier progressif de Supplemental Biologics License Application (sBLA) auprès de la FDA pour LEQEMBI IQLIK, une formulation sous-cutanée en auto-injecteur de lecanemab-irmb, bénéficiant du statut Fast Track. Cette nouvelle formulation permettrait l'administration à domicile de LEQEMBI dès le début du traitement chez les patients atteints d’Alzheimer à un stade précoce.
L'auto-injecteur offrirait une dose initiale hebdomadaire de 500 mg (deux injections de 250 mg) en alternative à l'administration intraveineuse toutes les deux semaines. Chaque injection prend environ 15 secondes. Si elle est approuvée, LEQEMBI IQLIK serait le premier traitement anti-amyloïde permettant l'injection à domicile depuis l'initiation jusqu'à l'entretien, ce qui pourrait réduire l'utilisation des ressources de santé.
LEQEMBI est actuellement approuvé dans 48 pays et en cours d'examen dans 10 autres. Le médicament cible de manière unique à la fois les plaques amyloïdes et les protofibrilles dans le traitement de la maladie d'Alzheimer.
Eisai und Biogen (NASDAQ:BIIB) haben eine gestaffelte Einreichung einer Supplemental Biologics License Application (sBLA) bei der FDA für LEQEMBI IQLIK begonnen, eine subkutane Autoinjektor-Formulierung von Lecanemab-irmb, unter Fast Track-Status. Diese neue Formulierung würde die Heimanwendung von LEQEMBI ab Beginn der Behandlung für Patientinnen und Patienten mit frühstadialer Alzheimer-Krankheit ermöglichen.
Der Autoinjektor würde eine wöchentlich beginnende Dosis von 500 mg (zwei Injektionen zu je 250 mg) als Alternative zur zweiwöchentlichen intravenösen Gabe ermöglichen. Jede Injektion dauert etwa 15 Sekunden. Bei Zulassung wäre LEQEMBI IQLIK die erste anti-amyloide Behandlung, die Injektionen von Beginn bis zur Erhaltungsbehandlung zu Hause erlaubt und somit den Einsatz von Gesundheitsressourcen potenziell reduziert.
LEQEMBI ist derzeit in 48 Ländern zugelassen und in weiteren 10 Ländern in Prüfung. Das Arzneimittel zielt sowohl auf Amyloid-Plaques als auch auf Protofibrillen bei der Behandlung der Alzheimer-Krankheit ab.
- First potential anti-amyloid treatment offering at-home injection from start
- Fast Track Status granted by FDA for subcutaneous formulation
- Significant reduction in administration time (15 seconds per injection)
- Potential reduction in healthcare resources compared to IV administration
- Wide global presence with approval in 48 countries
- Risk of serious ARIA (Amyloid-Related Imaging Abnormalities) side effects
- Higher risk of adverse events in ApoE ε4 homozygote patients
- Potential for serious hypersensitivity reactions including anaphylaxis
- Risk of infusion-related reactions (26% vs 7% placebo)
Insights
Eisai's FDA application for subcutaneous LEQEMBI could significantly improve Alzheimer's treatment accessibility while strengthening Biogen's commercial position.
Eisai's initiated rolling sBLA for LEQEMBI IQLIK represents a potentially significant advancement in Alzheimer's disease treatment delivery. This subcutaneous autoinjector formulation would enable at-home administration from initiation through maintenance, eliminating the current requirement for bi-weekly intravenous infusions during the starting phase.
The key innovation here is the 15-second injection time per autoinjector, providing patients and caregivers tremendous flexibility compared to current infusion requirements. This addresses one of the primary barriers to LEQEMBI adoption - the logistical challenges of regular infusion center visits.
From a regulatory perspective, Eisai secured Fast Track designation for this application, potentially accelerating the review timeline. The submission leverages data from the Phase 3 Clarity AD open-label extension, building on LEQEMBI's established efficacy profile.
The market implications are substantial. If approved, LEQEMBI would gain a significant competitive advantage as the only anti-amyloid treatment offering complete at-home administration. This could drive increased adoption rates among both physicians and patients, particularly in communities with limited infusion center access.
For healthcare systems, the subcutaneous formulation potentially reduces resource utilization by eliminating infusion preparation time, nursing oversight, and facility costs. This aligns perfectly with the increasing pressure to move care outside traditional settings.
With LEQEMBI already approved in 48 countries and under review in 10 more, this formulation enhancement could significantly strengthen the global commercial positioning of both Eisai and Biogen in the emerging Alzheimer's treatment landscape.
LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start to help patients and care partners treat this progressive, relentless disease
The sBLA is based on evaluation of subcutaneous (SC) lecanemab administration across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension (OLE), following the 18-month core study in individuals with early AD. Should the FDA approve the LEQEMBI IQLIK 500 mg SC dosing regimen (two 250 mg injections), the autoinjector could be used to administer a once weekly starting dose, as an alternative to bi-weekly (every two weeks) intravenous (IV) dosing. This would expand the option for patients and care partners to receive LEQEMBI treatment from initiation to maintenance at home, offering a choice between IV and SC administration. The current injection time for each LEQEMBI IQLIK autoinjector takes approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV maintenance dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall AD treatment pathway.
AD is a progressive, relentless 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 AD in two ways – targeting both amyloid plaque and protofibrils*, which can impact tau downstream.
LEQEMBI is currently approved in 48 countries and is under regulatory review in 10 countries.
Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
*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
INDICATION
LEQEMBI® is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
IMPORTANT SAFETY INFORMATION
WARNING: AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA)
|
CONTRAINDICATION
Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.
WARNINGS AND PRECAUTIONS
Amyloid-Related Imaging Abnormalities
Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.
Incidence of ARIA
Symptomatic ARIA occurred in
Incidence of ICH
ICH >1 cm in diameter was reported in
Risk Factors of ARIA and ICH
ApoE ε4 Carrier Status
Of the patients taking LEQEMBI,
Radiographic Findings of CAA
Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE ε4 allele is also associated with CAA.
The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.
Concomitant Antithrombotic or Thrombolytic Medication
In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH:
Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent.
Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI.
Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.
Radiographic Severity With LEQEMBI
Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in
Monitoring and Dose Management Guidelines
Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.
Hypersensitivity Reactions
Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.
Infusion-Related Reactions (IRRs)
IRRs were observed—LEQEMBI:
IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.
ADVERSE REACTIONS
- The most common adverse reactions reported in ≥
5% with LEQEMBI infusion every 2 weeks and ≥2% higher than placebo were IRRs (LEQEMBI:26% ; placebo:7% ), ARIA-H (LEQEMBI:14% ; placebo:8% ), ARIA-E (LEQEMBI:13% ; placebo:2% ), headache (LEQEMBI:11% ; placebo:8% ), superficial siderosis of central nervous system (LEQEMBI:6% ; placebo:3% ), rash (LEQEMBI:6% ; placebo:4% ), and nausea/vomiting (LEQEMBI:6% ; placebo:4% ) - Safety profile of LEQEMBI IQLIK for maintenance treatment was similar to LEQEMBI infusion. Patients who received LEQEMBI IQLIK experienced localized and systemic (less frequent) injection-related reactions (mild to moderate in severity)
LEQEMBI (lecanemab-irmb) is available:
- Intravenous infusion: 100 mg/mL
- Subcutaneous injection: 200 mg/mL
Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.
MEDIA CONTACTS | |
Eisai Co., Ltd. Public Relations Department TEL: +81 (0)3-3817-5120
Eisai Europe, Ltd. EMEA Communications Department +44 (0) 797 487 9419
Eisai Inc. ( Libby Holman +1-201-753-1945
| Biogen Inc. Madeleine Shin +1-781-464-3260
|
INVESTOR CONTACTS | |
Eisai Co., Ltd. Investor Relations Department TEL: +81 (0) 3-3817-5122 | Biogen Inc. Tim Power + 1-781-464-2442 |
Notes to Editors
1. About lecanemab (generic name, brand name: LEQEMBI®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). 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.2 It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.
Lecanemab has been approved in 48 countries and is under regulatory review in 10 countries. In January 2025, the supplemental Biologics License Application (sBLA) for intravenous (IV) maintenance dosing of the treatment was approved in the
Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is 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
2. About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
3. About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
4. About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the
5. About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.
Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab (LEQEMBI); the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof, including for lecanemab-irmb; the potential of lecanemab-irmb if approved to be the first and only anti-amyloid treatment to offer at-home injection; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements.
These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the
These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned "Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
References
- 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
- 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.
- Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503.
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FAQ
What is the new LEQEMBI IQLIK formulation that Biogen and Eisai are seeking FDA approval for?
How does the administration time of LEQEMBI IQLIK compare to traditional IV treatment?
What are the main advantages of LEQEMBI IQLIK over the current IV formulation?
How many countries has LEQEMBI been approved in as of September 2025?
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