Novartis Reports Results of Mayzent (siponimod) in P-III EXPAND Study for Secondary Progressive Multiple Sclerosis
Shots:
- The P-III EXPAND study involves assessing of Mayzent vs PBO in 1-651 patients with SPMS from 31 countries with varying levels of disability (Core Part)- EDSS scores of 3·0–6·5- followed by extended treatment with open-label BAF312 to evaluate long-term safety- tolerability and efficacy
- The P-III EXPAND study: 52% reduction in ARR in Mayzent group; reduction in the risk of 3mos. & 6mos. CDP; no differences in Timed 25-Foot Walk Test; 79% reduction in T2 lesion volume; 55% reduction in ARR; patients free from Gd-enhancing lesions & enlarging T2 lesions (89% vs 67% & 57% vs 37%). Post-hoc analysis from EXPAND study demonstrated a reduction in cGM and thalamic atrophy
- Mayzent is a S1P receptor modulator targeting S1P1 and S1P5 receptors- approved in multiple countries including the US for RMS- EU- Australia- Albania for SPMS- Canada and UAE for active SPMS whereas Switzerland- Japan and China regulatory filings are in progress
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