Anavex Life Sciences Announces Submission of Blarcamesine MAA for Treatment of Alzheimer’s Disease to EMA
Anavex Life Sciences has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for blarcamesine, an oral treatment for Alzheimer's Disease. The drug demonstrated clinically meaningful improvement over 48 weeks, with ADAS-Cog13 score improvements exceeding 2 points. The treatment shows superior numerical clinical efficacy compared to approved therapies while slowing neurodegeneration in early AD patients. Blarcamesine offers advantages including once-daily oral administration, no routine MRI monitoring requirement, and a favorable safety profile. There are approximately 7 million people with Alzheimer's in Europe, with care costs estimated at $439 billion in 2019.
Anavex Life Sciences ha presentato una domanda di autorizzazione alla commercializzazione (MAA) all'Agenzia europea per i medicinali (EMA) per blarcamesine, un trattamento orale per la malattia di Alzheimer. Il farmaco ha dimostrato miglioramenti clinicamente significativi nel corso di 48 settimane, con punteggi ADAS-Cog13 che superano le 2 punti. Il trattamento mostra una superiorità numerica in termini di efficacia clinica rispetto alle terapie approvate, rallentando la neurodegenerazione nei pazienti con Alzheimer precoce. Blarcamesine offre vantaggi tra cui la somministrazione orale una volta al giorno, l'assenza di requisiti di monitoraggio MRI di routine e un profilo di sicurezza favorevole. Ci sono circa 7 milioni di persone affette da Alzheimer in Europa, con costi assistenziali stimati a 439 miliardi di dollari nel 2019.
Anavex Life Sciences ha presentado una Solicitud de Autorización de Comercialización (MAA) a la Agencia Europea de Medicamentos (EMA) para blarcamesine, un tratamiento oral para la enfermedad de Alzheimer. El fármaco demostró una mejora clínicamente significativa a lo largo de 48 semanas, con mejoras en la puntuación ADAS-Cog13 que superan las 2 puntos. El tratamiento muestra una superioridad numérica en eficacia clínica en comparación con terapias aprobadas, al tiempo que ralentiza la neurodegeneración en pacientes con Alzheimer en etapas tempranas. Blarcamesine ofrece ventajas como la administración oral una vez al día, la ausencia de la necesidad de un monitoreo rutinario por RM y un perfil de seguridad favorable. Hay aproximadamente 7 millones de personas con Alzheimer en Europa, con costos de atención estimados en 439 mil millones de dólares en 2019.
Anavex Life Sciences는 blarcamesine에 대해 유럽의약청(EMA)에 마케팅 승인 신청서(MAA)를 제출했습니다. 이 구두약은 알츠하이머병을 위한 치료제입니다. 이 약물은 48주 동안 임상적으로 유의미한 개선을 보여주었으며, ADAS-Cog13 점수에서 2점 이상의 개선이 있었습니다. 이 치료법은 승인된 요법들과 비교하여 수치적으로 우수한 임상 효능을 보이며 초기 알츠하이머 환자의 신경퇴행을 늦춥니다. Blarcamesine은 하루에 한 번 복용할 수 있는 장점, 정기적인 MRI 모니터링 필요 없음, 그리고 유리한 안전성 프로필을 제공합니다. 유럽에는 약 700만 명의 알츠하이머 환자가 있으며, 2019년의 치료 비용은 약 4,390억 달러로 추정됩니다.
Anavex Life Sciences a soumis une demande d'autorisation de mise sur le marché (MAA) à l'Agence européenne des médicaments (EMA) pour blarcamesine, un traitement oral de la maladie d'Alzheimer. Le médicament a montré une amélioration cliniquement significative sur 48 semaines, avec des améliorations de plus de 2 points sur l'échelle ADAS-Cog13. Ce traitement présente une efficacité clinique supérieure par rapport aux thérapies approuvées tout en ralentissant la neurodégénérescence chez les patients atteints d'Alzheimer à un stade précoce. Blarcamesine offre des avantages tels qu'une administration orale quotidienne, l'absence de nécessité de surveillance par IRM de routine et un profil de sécurité favorable. Environ 7 millions de personnes souffrent de la maladie d'Alzheimer en Europe, avec des coûts de soins estimés à 439 milliards de dollars en 2019.
Anavex Life Sciences hat einen Antrag auf Marktzulassung (MAA) bei der Europäischen Arzneimittel-Agentur (EMA) für blarcamesine eingereicht, ein orales Medikament zur Behandlung von Alzheimer. Das Medikament zeigte über einen Zeitraum von 48 Wochen klinisch bedeutende Verbesserungen, wobei die ADAS-Cog13 Punktzahl um mehr als 2 Punkte anstieg. Die Behandlung zeigt eine überlegene numerische klinische Wirksamkeit im Vergleich zu genehmigten Therapien und verlangsamt die Neurodegeneration bei frühen AD-Patienten. Blarcamesine bietet Vorteile wie die einmal tägliche orale Verabreichung, keine routinemäßige MRT-Überwachung und ein günstiges Sicherheitsprofil. In Europa gibt es etwa 7 Millionen Menschen mit Alzheimer, die Pflegekosten werden für 2019 auf 439 Milliarden Dollar geschätzt.
- Demonstrated clinically meaningful improvement over 48 weeks
- Superior numerical clinical efficacy compared to existing therapies
- No routine MRI monitoring required, reducing healthcare costs
- Once-daily oral administration offers convenience advantage over injectable treatments
- Large potential market with 7 million Alzheimer's patients in Europe
- Product still in investigational phase with no guarantee of approval
- Faces competition from established anti-beta amyloid monoclonal antibody drugs
Insights
The MAA submission for blarcamesine to the EMA marks a significant regulatory milestone for Anavex. The drug demonstrated meaningful clinical improvement in Alzheimer's disease with a 2+ point improvement in ADAS-Cog13 over 48 weeks, suggesting superior efficacy compared to existing treatments. Key advantages include:
- Oral administration once daily, offering convenience over injectable antibody treatments
- No requirement for routine MRI monitoring, reducing healthcare burden
- Dual benefits of cognitive improvement and neurodegeneration slowdown
- Favorable safety profile
With 7 million AD patients in Europe and costs of
This regulatory submission could significantly impact Anavex's market position in the $439 billion European dementia care market. The oral administration route provides a competitive advantage over existing injectable treatments, potentially improving patient compliance and reducing healthcare delivery costs. The projected doubling of European AD patients by 2030 presents a massive market opportunity. Success in Europe could pave the way for global expansion and validate the company's drug development platform. However, investors should note that regulatory approval is not guaranteed and commercialization timeline remains uncertain.
• First marketing authorization submission for blarcamesine
NEW YORK, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today announced the submission of the blarcamesine (ANAVEX®2-73) MAA (Marketing Authorization Application) to the European Medicines Agency (EMA). The MAA submission is for the treatment of Alzheimer’s Disease.
Overall, blarcamesine, a small molecule administered orally once daily, demonstrated clinically meaningful improvement over 48 weeks with primary endpoint ADAS-Cog13 score being larger than 2 points.1 This suggests superior numerical clinical efficacy compared to approved therapies while also slowing neurodegeneration in early AD patients. Blarcamesine’s safety profile indicates not requiring routine MRI monitoring, and the advantage of blarcamesine is that it is a small oral molecule that exerts clinical benefits on cognition and neurodegeneration and could be appealing because of its easy and convenient route of administration and good comparative safety profile.
There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.2 The World Health Organization (WHO) estimated the cost in Europe of caring for people with dementia, including Alzheimer's disease, at
“This MAA submission is the first for oral blarcamesine as we are requesting a review of the Marketing Authorization Application with the aim to move closer to bringing this therapy to patients with Alzheimer’s disease worldwide,” said Juan Carlos Lopez-Talavera, MD, PhD, Head of Research and Development of Anavex. “Blarcamesine’s safety and efficacy profile could represent a novel treatment that could be complementary or an alternative to anti-beta amyloid monoclonal antibody drugs.”
“It’s a remarkable milestone accomplishment and this regulatory submission in the EU represents an important step in our efforts to potentially bring the first oral novel treatment Alzheimer’s disease to the Alzheimer’s disease community,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “I would like to thank all involved and especially the participating families within our clinical development program, were we have seen that oral blarcamesine has the potential to slow the progression of this relentless and ultimately fatal disease.”
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com
1 Muir RT, Hill MD, Black SE, Smith EE. Minimal clinically important difference in Alzheimer's disease: Rapid review. Alzheimers Dement. 2024;20(5):3352-3363. doi:10.1002/alz.13770
2 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
3 Jönsson L. The personal economic burden of dementia in Europe. Lancet Reg Health Eur. 2022 Jul 25;20:100472. doi: 10.1016/j.lanepe.2022.100472. PMID: 35910037; PMCID: PMC9326307.
4 World Health Organization (WHO); 2021. Global status report on the public health response to dementia.
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