Swiss pharma firm Novartis has secured the European Commission (EC) approval for Mayzent (siponimod) to treat adult patients with secondary progressive multiple sclerosis (SPMS).

The European regulator has indicated Mayzent for the treatment of SPMS in adult patients with active disease, verified through relapses or imaging features of inflammatory activity.

European MS Platform president Pedro Carrascal said: “We are delighted by the news that there is now a treatment available for people in Europe living with active SPMS to potentially delay the progression of this debilitating disease.

“This treatment brings hope for improved care and quality of life to patients who have long been underserved.”

Mayzent is the first and only oral treatment indicated for SPMS patients with active disease

The company said that currently, no oral treatment is available, which could delay the disease progression for SPMS patients with active disease, and its Mayzent addresses the unmet need for SPMS patients.

Mayzent is a sphingosine 1-phosphate receptor modulator that selectively binds to S1P1 and S1P5 receptors, showing anti-inflammatory effects by preventing lymphocytes from leaving the lymph nodes and entering the central nervous system (CNS).

In addition, the EC approval is supported by the data from EXPAND, a randomised, double-blind, placebo-controlled Phase III clinical trial, that compared the efficacy and safety of Mayzent against placebo in SPMS patients with varying levels of disability.

In the clinical study, Mayzent has shown an overall consistent safety profile with the known effects of S1P receptor modulation, and has reduced 21% risk of three-month CDP, and delayed the risk of six-month CDP.

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.”