The U.S. Food and Drug Administration (FDA) has approved Mayzent tablets (siponimod) by Novartis for the treatment of Multiple Sclerosis (MC) including secondary progressive multiple sclerosis (SPMS) with active disease, relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS).
It is the first and only drug available for the patient to treat active MC.
Multiple sclerosis (MS) is a potentially disabling disease of the brain and spinal cord (central nervous system). It disrupts the flow of information between the brain and the body. MS is of four types: Clinically isolated syndrome (CIS), Relapse-remitting MS (RRMS), Primary progressive MS (PPMS) and Secondary progressive MS (SPMS). It generally affects between the age of 14 to 60 and symptoms are more aggressive in older people with age around 40 to 60.
Mayzent is the only drug available after 15 years and the first oral formulation. Mayzent is the first second-generation sphingosine 1-phosphate (S1P) receptor modulator to enter the MS market. It is more receptor-specific which improves efficacy and reduces cardiac side effects.
“One of the most important aims of MS treatment is delaying disability progression and preserving cognition,” said Paul Hudson, Chief Executive Officer, Novartis Pharmaceuticals in the company press release.
The approval is based on groundbreaking data from the Phase III EXPAND study, a randomized, double-blind, placebo-controlled study, comparing the efficacy and safety of Mayzent versus placebo in people living with SPMS. The drug has shown a safety profile that was overall consistent with the known effects of S1P receptor modulation.