August 25, 2016
Novartis has announced the results of the Phase III EXPAND study that evaluates the safety and efficacy of oral, once-daily, BAF312 (siponimod) in secondary progressive multiple sclerosis (SPMS). The study confirmed that BAF312 met its primary endpoint of a reduction in the risk of disability progression, compared with placebo. This EXPAND study represents the largest randomized, controlled study in SPMS to date.
Vasant Narasimhan, Global Head of Drug Development and Chief Medical Officer for Novartis, said: “SPMS is a particularly disabling form of MS, and there is a need for effective treatment options to help delay disability progression in those living with the condition. The positive EXPAND data are encouraging for a disease with such a high unmet need. We look forward to sharing the results at the upcoming ECTRIMS congress, and thank all of the study participants and investigators.”
Topline results of the EXPAND study, including primary and key secondary endpoints, will be presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), September 17th, in London, UK. In consultation with health authorities, Novartis will complete full analyses of the data and evaluate next steps.