European Commission approval for Mayzent to treat secondary progressive multiple sclerosis.- Novartis

Novartis announced the European Commission (EC) has approved Mayzent (siponimod) for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. Although every patient’s MS journey is unique, up to 80% of relapsing remitting MS (RRMS) patients will eventually transition to SPMS. Mayzent addresses an unmet need for SPMS patients with active disease who, until now, did not have an oral treatment that has been shown to be effective in delaying progression in this patient population. The European marketing authorization makes Mayzent the first and only indicated oral treatment proven in SPMS patients with active disease based on a randomized clinical trial of a broad range of SPMS patients. The EC’s approval is based on data from the EXPAND study, a randomized, double-blind, placebo-controlled trial, comparing the efficacy and safety of Mayzent versus placebo in a broad range of SPMS patients (EDSS score 3·0–6·5 at baseline). EXPAND included a subgroup of patients with active disease (n=779), defined as patients with relapses in the two years prior to the study and/or presence of Gd-enhancing T1 lesions at baseline. The baseline characteristics were similar except for signs of activity compared to the overall population. In the subgroup of Mayzent-treated patients with active disease, results showed :• The risk of three month and six month confirmed disability progression (CDP) was significantly reduced by 31% compared to placebo and by 37% compared to placebo, respectively. • Significant favorable outcomes in other relevant measures of MS disease activity, including annualized relapse rate (ARR – confirmed relapses), MRI disease activity and brain volume loss (brain shrinkage). Results in the overall population showed that Mayzent significantly reduced the risk of three-month CDP (primary endpoint; 21% reduction versus placebo, p=0.013) and meaningfully delayed the risk of six-month CDP (26% versus placebo, p=0.0058)2. Mayzent also has a meaningful benefit on cognition and demonstrated clinically relevant effects on cognitive processing speed.