Shots:

• The approval is based on P-III EXPAND study results assessing Mayzent vs PBO in 1-651 patients with SPMS from 31 countries aged 48yrs.
• P-III study results: reduction in risk of three-month & six-month confirmed disability progression (CDP) 21% & 26%- 33% reduction with relapse activity in the two years- 55% reduction in annualized relapse rate (ARR)- limited increase of T2 lesion volume by ~80- 89% free from gadolinium-enhancing lesions
• Mayzent (siponimod) is a sphingosine 1-phosphate receptor modulator binds to S1P1 and S1P5 receptors and is approved for relapsing forms of MS- including SPMS with active disease- relapsing remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS)

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