Health Canada Approves Mayzent to Treat Active SPMS

Health Canada has approved Novartis‘s Mayzent (siponimod) for the treatment of adults with active secondary progressive multiple sclerosis (SPMS) to delay the progression of physical disability.

Active disease is determined either by the presence of relapses or magnetic resonance imaging features characteristic of inflammatory activity.

Multiple sclerosis (MS) results from the attack to the central nervous system (CNS, comprising the brain and spinal cord) by the body’s own immune system. Most people with MS are diagnosed first with the relapsing-remitting form of the disease (RRMS), and most of them (around 85%) go on to develop SPMS, which is characterized by progressive worsening of disability with either fewer or no relapses, and nerve damage or loss.

Mayzent binds to the sphingosine-1-phosphate receptor on immune cells, and prevents these cells from leaving the lymph nodes. As a consequence, immune cells can no longer enter the CNS and cause damage. Mayzent is the first oral treatment to be granted approval for active SPMS.

Mayzent’s approval follows positive results of the Phase 3 EXPAND clinical trial (NCT01665144) evaluating the safety and efficacy of the therapy among 1,651 patients with active or non-active SPMS recruited across 31 countries. Participants were randomly assigned to receive 2 mg of Mayzent or a placebo, once a day, and were followed for up to three years.

Results from active SPMS patients showed that Mayzent, compared with placebo, significantly reduced the risk of disability progression by 31% at three months, and by 37% at six months. Mayzent treatment is also associated with a significant reduction in annualized relapse rates (by 46%), inflammatory disease activity, number of new brain lesions, and brain shrinkage.

Mayzent is well-tolerated and its safety profile is consistent with those observed in trials of similar MS therapies.

“We are pleased to see that Health Canada has approved an additional therapeutic advancement targeting progressive forms of the disease,” said Pamela Valentine, PhD, president and CEO at the MS Society of Canada. “MS is unpredictable. The more treatment options for people with MS, the more opportunities they have in managing their individual symptoms throughout their MS journey.”

Mayzent is already approved in Europe, Australia, and in the United States. In the U.S., it also is approved for adults with clinically isolated syndrome and RRMS.