Novartis to seek approval for first SPMS (multiple sclerosis) therapy after the positive Phase III results

Novartis could have the first therapy which could delay disability progression secondary progressive multiple sclerosis (SPMS) if it gets the approval after the positive Phase III results filling takes place in early 2018, as it said Monday. It also plans to file the therapy for European market in Q3 2018, as it said would wait the outcome of a scientific advice consultation with the European Medicines Agency (EMA).

The drugmaker said that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) were published in the peer-reviewed journal The Lancet. According to Novartis, the pivotal results show significant reductions in the risk of three- (primary endpoint) and six-month confirmed disability progression with siponimod versus placebo and favorable outcomes in other relevant measures of MS disease activity. Novartis said that siponimod would be the first disease-modifying therapy  – if approved – to delay disability progression in typical SPMS patients, including many who had reached a non-relapsing stage and high level of disability.

SPMS is a form of MS that leads to progressive, irreversible disability, largely independent of relapses. Patients transition to SPMS after an initial phase of relapsing-remitting MS (RRMS), the most commonly diagnosed type of MS. There is a high unmet medical need for new treatments that are safe and effective for patients with SPMS, Novartis noted.

Professor Ludwig Kappos, University Hospital Basel and Principal Investigator of EXPAND, said that according to the study’s results, siponimod can delay disability progression in typical established SPMS patients, where other approaches tested so far have been unsuccessful. He noted that the data are all the more impressive when considering that the majority of patients already had advanced disability when starting treatment in the trial.

The trial was the part of Novartis’s dedication to advancing MS research and pioneering solutions for people living with SPMS – a complex, debilitating disease, said Danny Bar-Zohar, Global Head, Neuroscience Development for Novartis. 

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