Mayzent is claimed to the first oral drug to treat secondary progressive MS with active disease.
Mayzent is approved across the MS spectrum for clinically isolated syndrome (CIS), relapsing remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (SPMS), with most patients not requiring a first dose observation.
The FDA’s Center for Drug Evaluation and Research neurology products division director Dr Billy Dunn said: “We are committed to continuing to work with companies that are developing additional treatment options for patients with multiple sclerosis.”
Mayzent is a next generation and selective sphingosine 1-phosphate receptor modulator developed to treat relapsing forms of multiple sclerosis (RMS), including CIS, relapsing remitting disease and active secondary progressive disease, in adults.
Mayzent also holds capacity to enter the CNS and directly bind to the S1P5 and S1P1 sub-receptors on specific cells in the CNS to enhance re-myelination and prevent inflammation.
The approval was based on data from the phase III Expand randomized, double-blind and placebo-controlled study designed to compare the efficacy and safety of Mayzent against placebo in people living with SPMS.
According to the company, Mayzent significantly decreased the risk of three-month confirmed disability progression (CDP), which is a primary endpoint of the trial.
The trial also demonstrated significant favorable outcomes in other relevant measures of MS disease activity, including cognition, MRI disease activity and brain volume loss, said the company.
Expand trail is claimed to be the largest randomized and controlled study in SPMS to date, including 1,651 people with a diagnosis of SPMS from 31 countries.
Novartis Pharmaceuticals CEO Paul Hudson said: “With Mayzent, SPMS patients with active disease will have access to the first effective oral therapy directed towards disease progression, even when MS transitions to a stage where deterioration is less dependent on the usual relapse activity.
“Mayzent is a testament to the Novartis mission to reimagine medicine. We are delighted that our ongoing commitment to stop MS has led to a much awaited treatment for these patients in need.”