Novartis’ Mayzent (siponimod) Receives FDA’s Approval for Patients with Secondary Progressive Multiple Sclerosis (SPMS)
Novartis’ LysaKare (arginine hydrochloride/lysine hydrochloride) Solution Receives CHMP’s Positive Opinion for Reduction of Kidney Exposure to Radiation During PPRT with Lutathera
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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