Shots:

• The NDA and MAA Acceptance of Siponimod is based on P-III EXPAND study- assessing Siponimod vs PBO in adults with Secondary Progression Multiple Sclerosis (SPMS) evaluating its safety and efficacy
• P-III EXPAND study results: reduction in risk confirmed disability progression @3mos 21% & @6mos. 26%. Additionally- P-II BOLD study was conducted to evaluate Siponimod 2mg vs PBO in RRMS demonstrating ARR @6mos. (0.20 vs 0.58)
• The company used review voucher to expedite the FDA’s review process for Siponimod and also received fast track authorization procedure from Swisssmedic- in Switzerland
• Siponimod is a selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor

Ref: Novartis | Image: Fortune