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Blarcamesine Receives EMA Filing Acceptance for Treatment of Alzheimer's Disease
Anavex Life Sciences Anavex Life Sciences (US:AVXL) GlobeNewswire News Room·2024-12-23 12:00

Core Insights - Blarcamesine is a novel oral treatment for early Alzheimer's disease that has shown meaningful clinical efficacy and a favorable safety profile [1][9][10] - The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for blarcamesine, indicating progress towards broader patient access in Europe [7][8] Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for neurodegenerative diseases, including Alzheimer's and Parkinson's disease [7][10] - The company has successfully completed multiple clinical trials for its lead drug candidate, ANAVEX®2-73 (blarcamesine), demonstrating its potential to restore cellular homeostasis and slow disease progression [10] Clinical Trial Results - The Phase IIb/III trial (ANAVEX®2-73-AD-004) and its open-label extension (ATTENTION-AD) have provided data supporting the efficacy of blarcamesine in early Alzheimer's disease [2][8] - Blarcamesine demonstrated a clinically meaningful improvement over 48 weeks, with a primary endpoint ADAS-Cog13 score improvement greater than 2 points, suggesting superior efficacy compared to existing therapies [9][10] Mechanism of Action - Blarcamesine works by enhancing autophagy through SIGMAR1 activation, which is crucial for countering Alzheimer's disease pathology [2][8][10] - The drug's differentiated mechanism of action positions it as a potential alternative or complement to injectable anti-beta amyloid monoclonal antibody therapies [9] Market Context - There are approximately 7 million people in Europe with Alzheimer's disease, a number projected to double by 2030, highlighting the urgent need for effective treatments [10] - The economic burden of dementia care in Europe was estimated at $439 billion in 2019, underscoring the significance of developing new therapeutic options [10]