Siponimod granted European licence for active secondary progressive MS

The European Commission has granted marketing authorization for siponimod (Mayzent) for active secondary progressive MS. This follows a recommendation from the European Medicines Agency that a licence should be granted.

• Active secondary progressive MS is defined as people experiencing relapses or showing signs of inflammation in MRI scans.

Siponimod will now need to be assessed by NICE and the SMC to decide NHS availability in the UK. NICE has started the process with a decision due to be published in May this year. SMC has also scheduled an appraisal, with the decision published in July. The MS Trust is contributing to both appraisals. If the appraisals are successful, siponimod could potentially be available as an NHS treatment from September this year.

About siponimod

Siponimod is taken as a tablet, once a day.

In clinical trials for secondary progressive MS, siponimod reduced the risk of disability progression by 26% compared to placebo. Further analysis indicated a 37% reduction in the risk of progression for those with active SPMS (defined as those who had relapsed in the two years prior to starting the trial).

In clinical trials, low white blood cell count, increased liver enzyme levels, slower heart rate when starting treatment, macular oedema (swelling in the back of the eye affecting vision), high blood pressure, shingles, and convulsions occurred more frequently with siponimod than with placebo.