Although there are more than 20 FDA-approved disease-modifying therapies (DMTs) for multiple sclerosis (MS), companies continue to bring new products to market. Zitter Insights found that the majority of payers expect to manage the newest entrant, the Janssen Pharmaceutical Companies of Johnson & Johnson’s Ponvory (ponesimod), to label.
On March 19, the FDA approved Ponvory to treat adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The approval was based in part on the Phase III OPTIMUM study, which showed the product reduced annual relapses by 30.5%, compared with Sanofi’s Aubagio (teriflunomide). It also reduced brain lesions by more than 50%.
The sphingosine 1-phosphate (S1P) receptor modulator joins other oral agents within that class: Gilenya (fingolimod) and Mayzent (siponimod), both from Novartis Pharmaceuticals Corp., and Bristol Myers Squibb’s Zeposia (ozanimod).