Novartis has secured approval for Mayzent (siponimod) in the European Union (EU) for the treatment of secondary progressive multiple sclerosis (SPMS) in adults.
The approval for Mayzent from the European Commission (EC) is for SPMS with active disease, confirmed by relapses or imaging features of inflammatory activity.
The sphingosine 1-phosphate receptor modulator (S1PR modulator) was approved for the same indication by the US Food and Drug Administration (FDA) in March 2019.
According to Novartis, the marketing authorisation secured in the EU makes the S1PR modulator the first approved oral treatment in the region for SPMS patients having active disease.
The EC’s approval was granted based on the findings of the phase 3 EXPAND study, which studied the efficacy and safety of the S1PR modulator against placebo in 1,651 SPMS patients with varying levels of disability.
Novartis said 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.
Patients treated with the S1PR modulator also had favourable outcomes in other relevant measures of MS disease activity that were significant compared to placebo. Included in these are annualized relapse rate (ARR – confirmed relapses), MRI disease activity, and brain volume loss.
Novartis Pharmaceuticals neuroscience franchise global head Max Bricchi said: “As the only indicated oral therapy proven for people living with SPMS with active disease, we are pleased that the European approval of Mayzent will help change the conversation about progressing MS and expand possibilities for patients and their caregivers.
“Delaying progression is hugely important for people living with MS who want to maintain independence longer and today’s decision gives them a chance to achieve this goal. We are dedicated in our mission to reimagine medicine and enable brighter futures for people with severe progressive diseases like MS.”
Mayzent has been designed to bind selectively to the S1P1 and S1P5 receptors. By binding to the S1P1 receptor, it stops the lymphocytes from moving out of the lymph nodes and entering the central nervous system (CNS) of MS patients.
As per Novartis, the S1PR modulator enters the CNS as well where it binds to the S1P5 sub-receptor on astrocytes, oligodendrocytes, and other specific cells. In preclinical models of MS, Mayzent had generated pro-remyelinating and neuroprotective effects.