Policy & Regulation
EMA approves Novartis' Mayzent
22 January 2020 -

Novartis (SWX: NOVN) a pharmaceutical company reported on Monday that it has been granted a licience for Mayzent (siponimod), the first oral treatment for secondary progressive multiple sclerosis (SPMS) with active disease, from the European Medicines Agency (EMA).

The company said that Mayzent (siponimod) is intended for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.

This approval was based on the findings of the phase three EXPAND study that studied the efficacy and safety of the sphingosine 1-phosphate receptor modulator against placebo in 1,651 secondary progressive multiple sclerosis patients with varying levels of disability.

Novartis claimed that in the Mayzent treatment arm, the risk of three month and six month confirmed disability progression (CDP) was reduced significantly by 31% and 37%, respectively in comparison to placebo.