Siponimod to treat progressive MS in EU

March 6, 2020 0 By FM

The European Commission has approved siponimod for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease, Novartis said.

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 siponimod 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 siponimod-treated patients with active disease, results showed that 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. 

Siponimod is a sphingosine 1-phosphate receptor modulator that selectively binds to S1P1 and S1P5 receptors. In relation to the S1P1 receptor, it prevents the lymphocytes from egressing the lymph nodes and as a consequence, from entering the central nervous system (CNS) of patients with MS. This leads to the anti-inflammatory effects of the drug. 

Siponimod also enters the CNS and binds to the S1P5 sub-receptor on specific cells in the CNS, including astrocytes and oligodendrocytes and has shown pro-remyelinating and neuroprotective effects in preclinical models of MS.