Novartis’ Mayzent (siponimod) Receives EC’s Approval to Treat Patients with Secondary Progressive Multiple Sclerosis with Active Disease
Shots:
- The EC’s approval is based on P-III EXPAND study assessing Mayzent vs PBO in patients with SPMS with active disease defined as patients with relapses in the two years prior to the study and/or presence of Gd-enhancing T1 lesions at baseline
- Results in patients with active disease & in overall population: reduction in three‑month and six‑month CDP (31% and 37% & 21% and 26%) respectively; 79% reduction in T2 lesion volume; 55% reduction in ARR; patients free from Gd enhancing lesions (89% vs 67%); from T2 lesions (57% vs 37%)
- Mayzent is a sphingosine 1-phosphate receptor modulator, selectively targeting S1P1 and S1P5 receptors and has received the US FDA’s & TGA’s approval in Mar & Nov’2019 respectively
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