New Data Presented at AAIC Demonstrates Investigational LEQEMBI® (lecanemab-irmb) 360 mg Subcutaneous Maintenance Dosing Could Offer a New Option for Ongoing Treatment of Early Alzheimer's Disease
Biogen (NASDAQ:BIIB) and Eisai presented new data for LEQEMBI® (lecanemab-irmb) at AAIC 2025, showcasing promising results for a 360mg subcutaneous maintenance dosing option for early Alzheimer's disease treatment. The subcutaneous autoinjector (SC-AI) demonstrated comparable efficacy and safety to the intravenous formulation.
Key findings show that transitioning to weekly 360mg SC-AI after 18 months of IV treatment maintains clinical benefits, with less than 1% systemic injection reactions compared to 26% with IV. Human factors studies revealed 95% successful administration rates, with high satisfaction among patients, caregivers, and healthcare professionals. The FDA has set a PDUFA date of August 31, 2025 for the SC-AI formulation.
The development aims to provide a more convenient treatment option, allowing home administration and reducing the need for infusion center visits.Biogen (NASDAQ:BIIB) ed Eisai hanno presentato nuovi dati su LEQEMBI® (lecanemab-irmb) all'AAIC 2025, mostrando risultati promettenti per un'opzione di dosaggio di mantenimento sottocutaneo da 360 mg nel trattamento precoce della malattia di Alzheimer. L'autoiniettore sottocutaneo (SC-AI) ha dimostrato efficacia e sicurezza comparabili alla formulazione endovenosa.
I risultati principali indicano che il passaggio a una somministrazione settimanale di 360 mg SC-AI dopo 18 mesi di trattamento endovenoso mantiene i benefici clinici, con meno dell'1% di reazioni sistemiche all'iniezione rispetto al 26% con la somministrazione endovenosa. Studi di fattori umani hanno evidenziato un tasso di somministrazione riuscita del 95%, con alta soddisfazione tra pazienti, caregiver e operatori sanitari. La FDA ha fissato una data PDUFA per il 31 agosto 2025 per la formulazione SC-AI.
Lo sviluppo mira a offrire un'opzione terapeutica più comoda, permettendo la somministrazione a domicilio e riducendo la necessità di visite nei centri di infusione.
Biogen (NASDAQ:BIIB) y Eisai presentaron nuevos datos sobre LEQEMBI® (lecanemab-irmb) en el AAIC 2025, mostrando resultados prometedores para una opción de dosis de mantenimiento subcutánea de 360 mg en el tratamiento temprano de la enfermedad de Alzheimer. El autoinyector subcutáneo (SC-AI) demostró eficacia y seguridad comparables a la formulación intravenosa.
Los hallazgos clave indican que la transición a una dosis semanal de 360 mg SC-AI tras 18 meses de tratamiento intravenoso mantiene los beneficios clínicos, con menos del 1% de reacciones sistémicas a la inyección en comparación con el 26% con la administración intravenosa. Los estudios de factores humanos revelaron una tasa de administración exitosa del 95%, con alta satisfacción entre pacientes, cuidadores y profesionales de la salud. La FDA ha establecido una fecha PDUFA para el 31 de agosto de 2025 para la formulación SC-AI.
El desarrollo busca ofrecer una opción de tratamiento más conveniente, permitiendo la administración en casa y reduciendo la necesidad de visitas a centros de infusión.
Biogen (NASDAQ:BIIB)과 Eisai는 AAIC 2025에서 LEQEMBI®(lecanemab-irmb)의 새로운 데이터를 발표하며, 초기 알츠하이머병 치료를 위한 360mg 피하 유지용량 옵션의 유망한 결과를 선보였습니다. 피하 자동 주입기(SC-AI)는 정맥 주사 제형과 유사한 효능과 안전성을 입증했습니다.
주요 결과에 따르면, 18개월간의 정맥 주사 치료 후 주 1회 360mg SC-AI로 전환해도 임상적 이점이 유지되며, 정맥 주사 대비 1% 미만의 전신 주사 반응을 보였습니다(정맥 주사는 26%). 인간 공학 연구에서는 95%의 성공적인 투여율과 환자, 보호자, 의료진 모두 높은 만족도를 나타냈습니다. FDA는 SC-AI 제형에 대해 2025년 8월 31일 PDUFA 날짜를 지정했습니다.
이번 개발은 가정에서 투여가 가능하도록 하여 편리함을 높이고, 주입 센터 방문 필요성을 줄이는 것을 목표로 합니다.
Biogen (NASDAQ:BIIB) et Eisai ont présenté de nouvelles données sur LEQEMBI® (lecanemab-irmb) lors de l'AAIC 2025, mettant en avant des résultats prometteurs pour une option de dose d'entretien sous-cutanée de 360 mg dans le traitement précoce de la maladie d'Alzheimer. L'autoinjecteur sous-cutané (SC-AI) a démontré une efficacité et une sécurité comparables à la formulation intraveineuse.
Les résultats clés montrent que la transition vers une administration hebdomadaire de 360 mg SC-AI après 18 mois de traitement IV maintient les bénéfices cliniques, avec moins de 1 % de réactions systémiques à l'injection contre 26 % avec l'administration IV. Les études sur les facteurs humains ont révélé un taux de réussite d'administration de 95 %, avec une grande satisfaction parmi les patients, les aidants et les professionnels de santé. La FDA a fixé une date PDUFA au 31 août 2025 pour la formulation SC-AI.
Ce développement vise à offrir une option de traitement plus pratique, permettant une administration à domicile et réduisant la nécessité de visites en centre d'infusion.
Biogen (NASDAQ:BIIB) und Eisai präsentierten auf der AAIC 2025 neue Daten zu LEQEMBI® (lecanemab-irmb), die vielversprechende Ergebnisse für eine 360 mg subkutane Erhaltungsdosis bei der Behandlung der frühen Alzheimer-Krankheit zeigen. Der subkutane Autoinjektor (SC-AI) zeigte eine vergleichbare Wirksamkeit und Sicherheit zur intravenösen Formulierung.
Wesentliche Erkenntnisse zeigen, dass der Übergang zu einer wöchentlichen 360 mg SC-AI nach 18 Monaten IV-Behandlung die klinischen Vorteile erhält, mit weniger als 1 % systemischen Injektionsreaktionen im Vergleich zu 26 % bei IV. Studien zu Humanfaktoren zeigten eine 95 % Erfolgsrate bei der Anwendung sowie hohe Zufriedenheit bei Patienten, Betreuern und medizinischem Fachpersonal. Die FDA hat für die SC-AI-Formulierung einen PDUFA-Termin am 31. August 2025 festgelegt.
Die Entwicklung zielt darauf ab, eine bequemere Behandlungsoption zu bieten, die die Anwendung zu Hause ermöglicht und die Notwendigkeit von Besuchen in Infusionszentren reduziert.
- Subcutaneous maintenance dosing shows comparable efficacy to IV formulation
- Significantly lower injection reaction rates (<1%) compared to IV administration (26%)
- 95% successful administration rate in human factors study
- High satisfaction rates among patients, caregivers, and healthcare professionals
- Potential for home administration, reducing need for infusion center visits
- Zero ARIA-E cases observed in 49 patients treated with 360mg SC weekly maintenance
- Requires 18 months of IV treatment before transitioning to SC maintenance therapy
- Limited mean treatment duration of 6 months in safety assessment
Insights
Biogen's LEQEMBI subcutaneous autoinjector shows comparable efficacy to IV administration with better convenience and fewer infusion reactions.
The data presented at AAIC 2025 demonstrates that LEQEMBI's subcutaneous autoinjector (SC-AI) could significantly enhance treatment accessibility for early Alzheimer's disease patients. The study shows that transitioning to a weekly 360 mg SC-AI dose after 18 months of initiation therapy maintains clinical and biomarker benefits comparable to biweekly IV dosing, with equivalent impacts on key clinical outcomes and biomarkers.
Two critical advantages emerge from the SC formulation data: First, the safety profile shows dramatically reduced infusion/injection reactions - just 1% with SC compared to 26% with IV administration. Second, usability studies demonstrated exceptional patient acceptance, with 95% of participants successfully administering the dose and reporting high satisfaction with the device.
The pharmacological significance extends beyond convenience. LEQEMBI's dual mechanism targeting both protofibrils and amyloid plaque positions it uniquely in the Alzheimer's treatment landscape. Protofibrils are considered particularly damaging to neurons through multiple pathways - both by increasing insoluble amyloid plaque formation and by directly compromising neuronal signaling.
This maintenance dosing approach addresses a fundamental challenge in Alzheimer's therapy: biomarker reaccumulation and return to placebo-level decline when treatment stops. The subcutaneous option provides a more sustainable long-term treatment pathway after the critical 18-month initiation period, potentially improving real-world adherence and outcomes while reducing healthcare system burden by shifting from infusion centers to home administration.
Lecanemab subcutaneous autoinjector has the potential to become a new expanded treatment option for patients with early Alzheimer's disease, their care partners and healthcare professionals, with results showing a comparable efficacy and safety profile to the intravenous formulation
Importance of Ongoing Treatment and SC Development Program
Due to the reaccumulation of AD biomarkers and return to placebo rate of decline after therapy is stopped1, Eisai is investigating a new lecanemab SC maintenance treatment option following 18 months of IV therapy so patients can continue to fight this progressive, relentless disease.
Clinical trials of lecanemab SC were conducted as a sub-study of the open-label extension (OLE) following the core Phase 3 Clarity AD study in individuals with early AD, to evaluate a range of doses administered by SC vial or autoinjector. Eisai has developed a SC-AI for maintenance therapy at a dose of 360 mg weekly and a 500 mg SC-AI is being developed for initiation dosing.
Similar Impact on Clinical Outcomes and Biomarkers with IV and SC Dosing
The pharmacology (PK/PD), clinical (efficacy endpoints such as CDR-SB) and biomarker (amyloid PET and blood biomarkers) relationships established with extensive clinical data supported the FDA approval of IV maintenance therapy after the initial 18 months of treatment and support the investigational SC maintenance dose option.
- Data supports that transitioning to a weekly 360 mg SC AI dose of lecanemab after 18 months of initiation dose (10 mg/kg IV biweekly) maintains clinical and biomarker benefits comparable to continued biweekly IV dosing.
- Clinical and biomarker responses at 48 months with monthly IV maintenance dosing are similar to the responses with ongoing biweekly dosing whether patients are amyloid positive (>30 CL) or negative (<30 CL) at 18 months.
- Data shows the 500 mg SC AI has equivalent exposure as the initial treatment regimen of 10 mg/kg IV biweekly up to 18 months for amyloid removal, efficacy, and ARIA-E.
Safety Matters
The safety profile of 360 mg weekly SC maintenance dosing was shown to be consistent with that of IV maintenance therapy, with <
Study Participants Successfully Administered SC-AI and Found it Easy to Use
To optimize the safe and effective use of SC autoinjector (SC-AI), additional studies were conducted, including a human factors (HF) study and a tolerability assessment of the device.
The HF Study involved 110 participants (63 early AD patients, 32 care partners, and 15 healthcare professionals: HCPs) to assess the appropriate administration of lecanemab SC-AI. Overall,
The Autoinjector Device Acceptability Study involved 126 participants (25 early AD patients, 50 care partners, and 51 HCPs), to evaluate the device's ease of use, convenience and feasibility of administration. As an interim outcome, over
These studies and evaluations of lecanemab SC-AI have demonstrated that the investigational SC-AI offers efficacy and safety comparable to IV administration with the potential to reduce the incidence of infusion site adverse events. From the perspective of patients and care partners, benefits included the ability to use the device at home, shortening treatment time, and to continue treatment without having to worry about visiting an infusion center. From the perspective of HCPs, they reported that the device has the potential to provide a new option for patients who are benefiting from lecanemab to continue the treatment. The SC formulation has the potential to reduce medical preparation and administration time related to IV therapy. These factors suggest that the SC AI may play an important role in continuing treatment for early AD.
This release is based on the content of the presentations given at AAIC, "Featured Research Session #4-13-FRS-C: Lecanemab Subcutaneous Formulation for Maintenance Dosing: The Potential of a New and Convenient Option for Ongoing Treatment in Early Alzheimer's Disease," held at 9:00 AM on Wednesday, July 30, and also includes some content from the Developing Topics session held at 8:00 AM on Sunday, July 27, entitled "Patient, Care Partner, and Health Care Professional Opinion of the Lecanemab Autoinjector for Subcutaneous Delivery in Early Alzheimer's Disease Patients."
Eisai serves as the lead for lecanemab's development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
* Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.1 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD. 2
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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 46 countries and is under regulatory review in 11 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; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; 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. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such 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.
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FAQ
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