Novartis data show early treatment with Mayzent® (siponimod) delays disability progression and show benefits in cognitive performance in patients with secondary progressive multiple sclerosis (SPMS)

• Post hoc EXPAND analysis showed improvements in cognitive processing speed in patients with active and non-active SPMS treated with Mayzent¹

• Subgroup analyses of the EXPAND trial showed the value of early treatment initiation with Mayzent in patients with active SPMS as positive effects on disability, cognitive processing speed and relapse outcomes were sustained for up to five years²

• Results from EXCHANGE interim analysis presented at ACTRIMS-ECTRIMS reinforced its safety and tolerability profile when patients switched from an oral or injectable disease-modifying therapy (DMT) to Mayzent³

Basel, September 11, 2020 — Novartis announced today that Mayzent^® (siponimod) analyses from the Phase IIIb EXCHANGE and EXPAND trials showed Mayzent to be a safe treatment option that has benefits in cognitive performance and reduces the risk of disability progression in patients with progressing multiple sclerosis^1–3. The data were presented at the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting that is taking place September 11–13, 2020.

“One of the biggest goals for people living with MS is to be able to live their lives independently for as long as possible,” said Norman Putzki, M.D., Global Head of Development, Neuroscience. “The data presented today reinforce that through its beneficial effects on cognitive performance and delaying disability progression, and as an appropriate option for patients to safely switch to/from other treatments, Mayzent offers hope for people looking to achieve this important goal.”

The EXCHANGE study is a Phase IIIb prospective, six-month, open-label study evaluating the safety and tolerability of conversion to Mayzent from other disease-modifying therapies (DMTs) in patients with relapsing forms of multiple sclerosis (RMS), including active secondary progressive multiple sclerosis (SPMS). The interim analysis included 112 patients from 42 centers in the US who were eligible for the safety analysis³. The EXPAND study is a randomized, double-blind, placebo-controlled Phase III study, comparing the efficacy and safety of Mayzent versus placebo in patients with SPMS with varying levels of disability. The post hoc EXPAND analysis found that in patients with active disease, an increased chance for clinically relevant improvement was observed and patients with active SPMS early and continuously treated with Mayzent experienced lower risk of disability progression and cognitive decline than patients who delayed Mayzent treatment^1,2.

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References

1. Penner IK, Giovannoni G, Cree B, et al. Effect of siponimod on cognitive processing speed in SPMS patients with active and non-active disease. ePoster presentation at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting; September 2020
2. Giovannoni G, Kappos L, Fox RJ, et al. Sustained reduction of disability and cognitive decline with long-term siponimod treatments in patients with active SPMS: EXPAND data up to 5 years. ePoster presentation at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting; September 2020
3. Bar-Or A, Weinstock-Guttman B, Mao-Draayer Y, et al. Safety and tolerability of conversion to siponimod in patients with relapsing multiple sclerosis: interim results of the EXCHANGE study. ePoster presentation at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting; September 2020

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