FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease
Biogen (BIIB) and Eisai announced FDA approval for LEQEMBI's intravenous maintenance dosing schedule change from every two weeks to every four weeks for early Alzheimer's disease treatment. After 18 months of bi-weekly initiation phase, patients can transition to the four-week maintenance schedule or continue bi-weekly treatment.
The approval is supported by modeling data from Phase 2 and Clarity AD studies, predicting maintained clinical benefits with the new dosing regimen. LEQEMBI works by clearing both protofibrils and plaque, with data showing that treatment discontinuation leads to biomarker reaccumulation and clinical decline reversion.
The treatment demonstrated significant clinical benefits, reducing cognitive decline on the CDR-SB scale by -0.95 over three years compared to a matched natural history cohort. LEQEMBI is currently approved in multiple countries, including the US, Japan, and China, with pending applications in 17 other regions.
Biogen (BIIB) e Eisai hanno annunciato l'approvazione della FDA per la modifica del programma di somministrazione intravena di LEQEMBI, passando da ogni due settimane a ogni quattro settimane per il trattamento dell'Alzheimer precoce. Dopo un periodo iniziale di 18 mesi con somministrazioni bisettimanali, i pazienti possono passare al programma di mantenimento a quattro settimane o continuare il trattamento bisettimanale.
L'approvazione è supportata da dati di modellazione provenienti dagli studi di Fase 2 e Clarity AD, che prevedono benefici clinici mantenuti con il nuovo regime di dosaggio. LEQEMBI agisce eliminando sia i protofibrilli che le placche, con dati che mostrano che l'interruzione del trattamento porta a una riaccumulazione dei biomarcatori e a una regressione del declino clinico.
Il trattamento ha dimostrato benefici clinici significativi, riducendo il declino cognitivo sulla scala CDR-SB di -0,95 nell'arco di tre anni rispetto a un coorte di storia naturale abbinata. LEQEMBI è attualmente approvato in diversi paesi, tra cui Stati Uniti, Giappone e Cina, con domande in sospeso in altre 17 regioni.
Biogen (BIIB) y Eisai anunciaron la aprobación de la FDA para el cambio en el esquema de dosificación intravenosa de LEQEMBI, pasando de cada dos semanas a cada cuatro semanas para el tratamiento de la enfermedad de Alzheimer en fases tempranas. Después de 18 meses en la fase inicial de dosificación quincenal, los pacientes pueden transitar al esquema de mantenimiento de cuatro semanas o continuar con el tratamiento quincenal.
La aprobación está respaldada por datos de modelado de los estudios de Fase 2 y Clarity AD, que predicen beneficios clínicos mantenidos con el nuevo régimen de dosificación. LEQEMBI actúa eliminando tanto los protofibrilos como las placas, con datos que muestran que la interrupción del tratamiento lleva a una re-acumulación de biomarcadores y a una reversión del decline clínico.
El tratamiento demostró beneficios clínicos significativos, reduciendo el declive cognitivo en la escala CDR-SB en -0.95 durante tres años en comparación con una cohorte de historia natural emparejada. LEQEMBI está actualmente aprobado en varios países, incluidos Estados Unidos, Japón y China, con solicitudes pendientes en 17 regiones más.
Biogen (BIIB)와 Eisai는 조기 알츠하이머병 치료를 위한 LEQEMBI의 정맥 유지 용량 일정이 2주마다에서 4주마다로 변경된 FDA 승인을 발표했습니다. 18개월의 격주 시작 단계가 지난 후, 환자는 4주 유지 일정으로 전환하거나 계속해서 격주 치료를 받을 수 있습니다.
해당 승인은 2상 및 Clarity AD 연구의 모델링 데이터를 통해 뒷받침되며, 새로운 용량 요법으로 임상적 이점이 유지될 것으로 예측하고 있습니다. LEQEMBI는 프로토피브릴과 플라크 모두를 제거하는 방식으로 작용하며, 치료를 중단하면 바이오마커가 재축적되고 임상적 하락이 되돌려진다는 데이터가 있습니다.
이 치료법은 임상적 이점이 상당히 크며, 3년 동안 자연 역사 대조군에 비해 CDR-SB 척도에서 인지 감소를 -0.95 줄였습니다. LEQEMBI는 현재 미국, 일본, 중국을 포함한 여러 국가에서 승인되었으며, 17개 지역에서 추가 승인이 대기 중입니다.
Biogen (BIIB) et Eisai ont annoncé l'approbation de la FDA pour le changement du schéma posologique d'entretien intraveineux de LEQEMBI, passant de toutes les deux semaines à toutes les quatre semaines pour le traitement de la maladie d'Alzheimer précoce. Après 18 mois de phase d'initiation bi-hebdomadaire, les patients peuvent passer au schéma d'entretien de quatre semaines ou continuer leur traitement bi-hebdomadaire.
L'approbation est soutenue par des données de modélisation issues des études de Phase 2 et Clarity AD, prédisant des bénéfices cliniques maintenus avec le nouveau schéma de posologie. LEQEMBI agit en éliminant à la fois les protofibrilles et les plaques, avec des données montrant qu'un arrêt du traitement entraîne une réaccumulation de biomarqueurs et un retour à la dégradation clinique.
Le traitement a démontré des bénéfices cliniques significatifs, réduisant le déclin cognitif sur l'échelle CDR-SB de -0,95 sur une période de trois ans par rapport à une cohorte d'histoire naturelle appariée. LEQEMBI est actuellement approuvé dans plusieurs pays, dont les États-Unis, le Japon et la Chine, avec des demandes en instance dans 17 autres régions.
Biogen (BIIB) und Eisai haben die FDA-Zulassung für die Änderung des intravenösen Erhaltungsdosierungsschemas von LEQEMBI von alle zwei Wochen auf alle vier Wochen für die Behandlung der frühen Alzheimer-Krankheit angekündigt. Nach einer 18-monatigen Initiierungsphase mit zweiwöchentlicher Dosierung können die Patienten in den vierwöchigen Erhaltungszeitraum übergehen oder weiterhin alle zwei Wochen behandelt werden.
Die Genehmigung wird durch Modellierungsdaten aus den Phase-2- und Clarity AD-Studien unterstützt, die einen aufrechterhalteten klinischen Nutzen mit dem neuen Dosierungsregime vorhersagen. LEQEMBI wirkt, indem es sowohl Protofibrillen als auch Plaques beseitigt; Daten zeigen, dass eine Unterbrechung der Behandlung zur Wiederakkumulation von Biomarkern und zur Rückkehr des klinischen Rückgangs führt.
Die Behandlung zeigte signifikante klinische Vorteile und reduzierte den kognitiven Rückgang auf der CDR-SB-Skala um -0,95 über einen Zeitraum von drei Jahren im Vergleich zu einer passenden Kohorte mit natürlicher Historie. LEQEMBI ist derzeit in mehreren Ländern, darunter die USA, Japan und China, genehmigt, mit ausstehenden Anträgen in 17 anderen Regionen.
- FDA approval for less frequent maintenance dosing (every 4 weeks vs. every 2 weeks)
- Demonstrated -0.95 reduction in cognitive decline over three years vs. control group
- Global market expansion with approvals in multiple major markets
- Pending FDA review for subcutaneous autoinjector (PDUFA date: August 31, 2025)
- 26% of patients experienced infusion-related reactions vs. 7% for placebo
- 21% of patients showed ARIA (brain abnormalities) vs. 9% for placebo
- Risk of serious and life-threatening events including seizures and hemorrhages
- Higher adverse event risk for specific genetic groups (ApoE ε4 homozygotes)
Insights
The FDA approval of LEQEMBI's maintenance dosing marks a pivotal advancement for Biogen and Eisai's Alzheimer's franchise. The shift to once-every-four-weeks maintenance dosing after the initial 18-month period addresses a critical challenge in treatment adherence, potentially expanding the addressable patient population and improving long-term commercial viability.
The clinical data is particularly compelling, demonstrating a -0.95 reduction in cognitive decline over three years compared to natural history cohorts. This represents a meaningful benefit in preserving patient independence and daily functioning. The dual mechanism of action - targeting both protofibrils and plaque clearance - provides a unique therapeutic proposition in the market.
The global expansion is noteworthy, with approvals in 10 major markets including the US, Japan and China, plus a positive CHMP opinion in Europe. This broad geographic presence, combined with the pending subcutaneous autoinjector application (PDUFA: August 31, 2025), positions LEQEMBI for potentially significant market penetration.
However, investors should monitor several key factors: 1) The implementation of genetic testing requirements for ApoE ε4 status, which could impact prescription patterns 2) The safety profile, particularly regarding ARIA events in high-risk patients 3) The upcoming decision on the subcutaneous formulation, which could further enhance the competitive position in the maintenance setting.
Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment
Alzheimer's disease progression does not stop after plaque clearance; ongoing treatment with LEQEMBI can slow disease progression and prolong the benefits of therapy
The sBLA is based on modeling of observed data from the Phase 2 study (Study 201) and its long-term extension (LTE) as well as the Clarity AD study (Study 301) and its LTE study. Modeling simulations predict that transitioning to once every four weeks maintenance dosing after 18 months of once every two weeks treatment will maintain clinical and biomarker benefits of therapy. AD is a progressive, relentless disease caused by a continuous underlying neurotoxic process that begins before and continues after plaque removal.1,2,3 Only LEQEMBI works to fight AD in two ways: continuously clearing protofibrils and rapidly clearing plaque. This is important because with continuous administration, LEQEMBI clears highly toxic protofibrils* which can continue to cause neuronal injury even after the amyloid-beta (Aβ) plaque has been cleared from the brain.
Importance of Ongoing Treatment
- Data from the off-treatment period between the Study 201 (Phase 2) core study and LTE showed that discontinuation of treatment is associated with reaccumulation of amyloid PET and plasma and CSF biomarkers, and reversion to placebo rate of clinical decline.4
- For maintenance treatment, once every four weeks dosing regimen may be easier than once every two weeks dosing for patients and care partners to continue treatment for early AD.
- Ongoing treatment can slow disease progression and prolong the benefit of therapy,4 with the goal of helping patients maintain who they are for longer.
- In the Clarity AD core study (18 months), the mean change from baseline between the once every two weeks lecanemab treated group and the placebo group was -0.45 (P<0.0001) on the primary endpoint of the Clinical Dementia Rating-Sum of Boxes (CDR-SB) global cognitive and functional scale.
- Over three years of treatment across the Clarity AD core study and LTE, LEQEMBI reduced cognitive decline on the CDR-SB by -0.95** relative to a matched natural history cohort, showing clinically meaningful benefit for early AD patients.
- A change from 0.5 to 1 on the CDR score domains of Memory, Community Affairs and Home/Hobbies is the difference between slight impairment and loss of independence, such as people's ability to be left alone, remember recent events, participate in daily activities, complete household chores, function independently and engage in hobbies and intellectual interests.
LEQEMBI is approved in the
Eisai serves as the lead for lecanemab's development and regulatory submissions globally with both 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.5 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.6
**The lecanemab group was compared to the expected decline based on the Alzheimer's Disease Neuroimaging Initiative (ADNI) group. ADNI is a clinical research project launched in 2005 to develop methods to predict the onset of AD and to confirm the effectiveness of treatments. The ADNI observational cohort represents the exact population of those in Clarity AD study; matched ADNI participants show similar degree of decline to placebo group out to 18 months, supporting the appropriateness of the matching.
INDICATION
LEQEMBI® [(lecanemab-irmb) 100 mg/mL injection for intravenous use] 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) • Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause ARIA, characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. Serious intracerebral hemorrhages (ICH) >1 cm, some of which have been fatal, have been observed with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI. o Apolipoprotein E ε4 (ApoE ε4) Homozygotes: Patients who are ApoE ε4 homozygotes (~ Consider the benefit of LEQEMBI for the treatment of AD and the potential risk of serious ARIA events when deciding to initiate treatment with LEQEMBI. |
CONTRAINDICATION
LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients of LEQEMBI. 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:
In the event of an IRR, 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 ≥
Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.
Notes to Editors
- About lecanemab (LEQEMBI®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. 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 theU.S. ,7 Japan,8 China,9 South Korea,10 Hong Kong,11 Israel,12 theUnited Arab Emirates ,13 theUnited Kingdom ,14 Mexico,15 and Macau. In November 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval. Eisai has submitted applications for approval of lecanemab in 17 countries and regions.
LEQEMBI's approvals in these countries was based on Phase 3 data from Eisai's, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with lecanemab reduced clinical decline on CDR-SB by27% at 18 months compared to placebo.16,17 The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.21 with lecanemab and 1.66 with placebo (difference, −0.45;95% confidence interval [CI], −0.67 to −0.23; P<0.001). In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by people caring for patients with AD, noted a statistically significant benefit of37% compared to placebo. The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADL score was −3.5 in the lecanemab group and −5.5 in the placebo group (difference, 2.0;95% CI, 1.2 to 2.8; P<0.001). The ADCS MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. The most common adverse events (>10% ) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.
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 theU.S , funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine inSt. Louis , is ongoing and includes lecanemab as the backbone anti-amyloid therapy. - 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. - 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. - 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 theUK andEurope . For audiences based in theUK andEurope , please visit www.eisai.eu and Eisai EMEA LinkedIn. - About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' 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 statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "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 studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the
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FAQ
What is the new FDA-approved dosing schedule for BIIB's LEQEMBI maintenance treatment?
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