Swiss pharma giant Novartis snagged regulatory approval in the United States for its new multiple sclerosis treatment Mayzent (siponimod) and plans to have it available for prescribers and their patients by next week.
Novartis announced the U.S. Food and Drug Administration (FDA) approved siponimod, which will be sold under the name Mayzent, for the treatment of adults with relapsing forms of multiple sclerosis, including secondary progressive multiple sclerosis (SPMS) with active disease, relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS). Novartis used a voucher to expedite approval of Mayzent after the FDA accepted the company’s New Drug Application in October.
The approval of Mayzent bolsters Novartis’ MS pipeline, which includes the blockbuster treatment, Gilenya, which is expected to lose patent protection soon. In addition to Gilenya Novartis also markets Extravia as a treatment for relapsing forms of the disease.
The FDA approved Mayzent based on strong data from the Phase III EXPAND trial that showed siponimod-dosed patients gained a significant benefit in cognitive processing speed. Novartis also demonstrated that Mayzent generated significant improvements in patients, including a 21 percent decrease in the risk of disease progression. The Phase III results also showed that siponimod, a selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor, resulted in a 23 percent reduction of brain volume loss, limited T2 lesion volume from increasing by a mean of 79 percent, cut the annual relapse rate by 55 percent and showed reduced disease progression to about 26 percent at six months.
Novartis also submitted a Marketing Authorization Application to the European Medicines Agency. EU approval may come in late 2019.