Siponimod (Novartis) is a sphingosine-1-phosphate (S1P) agonist with selectivity for the S1P1 and S1P5 receptor subtypes. It is Novartis’s follow-on product to Gilenya (fingolimod; Novartis/Mitsubishi Tanabe), although the company is hoping that its binding profile will result in a differentiated clinical profile. It is also unique in that Novartis is developing the drug primarily for secondary progressive multiple sclerosis (SPMS), instead of relapsing-remitting multiple sclerosis (RRMS) where there is a clinical precedent for S1P modulators and a high likelihood of success in clinical development.
Siponimod is currently in Phase III development, with Novartis presenting positive topline results for its 1,530-patient Phase III EXPAND trial in September 2016. Novartis’s initial plans were to file siponimod for regulatory approval in 2019. However, it now appears that the company might be considering an earlier regulatory filing in SPMS on the basis of EXPAND’s impressive data.
LIST OF FIGURES 7 Figure 1: Siponimod for multiple sclerosis – SWOT analysis
8 Figure 2: Datamonitor Healthcare’s drug assessment summary of siponimod for multiple sclerosis
9 Figure 3: Datamonitor Healthcare’s drug assessment summary of siponimod for multiple sclerosis
11 Figure 4: Siponimod sales for multiple sclerosis across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES 5 Table 1: Siponimod drug profile
6 Table 2: Siponimod Phase III data in multiple sclerosis
12 Table 3: Siponimod sales for multiple sclerosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
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