EC approves Mayzent^® for secondary progressive multiple sclerosis

The European Commission (EC) has approved Mayzent (siponimod) for the treatment of adults with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.

Approximately 80 percent of relapsing remitting MS (RRMS) patients will experience SPMS and until now, there has been no oral therapeutic which could delay the progression of SPMS approved in Europe.

“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,” said Pedro Carrascal, President of the European MS Platform. “This treatment brings hope for improved care and quality of life to patients who have long been underserved.”

Mayzent is a sphingosine 1-phosphate receptor (S1P) modulator which selectively binds the S1P1 and prevents lymphocytes from entering the lymph nodes and the central nervous system (CNS). It can also bind to S1P5 on astrocytes and oligodendrocytes in the CNS. Both these actions prevent inflammation and are neuroprotective.

The approval, granted to Novartis, was based on results of the EXPAND study, a randomised, double-blind, placebo-controlled trial in SPMS patients which compared the safety and efficacy of Mayzent to a placebo.

A total of 779 of the participants had active SPMS and when treated with Mayzent found:

• Their risk of three-month confirmed disability progression (CDP) reduced by 31 percent compared to placebo
• Their risk of six-month CDP also fell by 37 percent compared to placebo
• Their annualised relapse rate, MRI disease activity and brain volume all reduced.

The trials also concluded Mayzent had a meaningful benefit on cognition, particularly cognitive processing speed.

“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,” said Max Bricchi, Global Head, Neuroscience Franchise, Novartis Pharmaceuticals. “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.”

The drug is already approved by the US Food and Drug Administration (FDA) for RRMS and by the Australian Therapeutic Goods Administration (TGA) for adults with SPMS. Novartis has additional regulatory filings are currently underway in Switzerland, Japan, Canada and China.