Additional Relevant Details The EC approval of ZINBRYTA is supported by results from two studies, including DECIDE, the largest and longest head-to-head Phase 3 study ever conducted in MS. The Phase 2b SELECT and Phase 3 DECIDE studies were global, randomized, double-blind, controlled studies that involved approximately 2,400 people living with RMS. Some patients in DECIDE were treated for up to three years.In DECIDE and SELECT, ZINBRYTA significantly reduced patients’ annualized relapse rate (ARR), the primary endpoint of the studies, by 45 percent compared to AVONEX up to 144 weeks and by 54 percent compared to placebo at 52 weeks (both p<0.0001), respectively. Analyses of these studies demonstrated the consistent effect of ZINBRYTA relative to placebo and AVONEX across various subgroups of patients defined by demographic and MS disease characteristics.

In addition to the statistically significant ARR, the Summary of Product Characteristics (SmPC) also includes the following ZINBRYTA clinical measures:

• Statistically significant effect on 24-week confirmed disability progression in ZINBRYTA-treated patients with a hazard ratio of 0.73 [95% Confidence Interval 0.55, 0.98].
• Statistically significant reduction in the number of new or newly enlarging T2 hyperintense lesions, the number of new T1 Gd-enhancing lesions and the mean number of new T1 hypointense lesions at 96 weeks.
• Reduced clinically meaningful worsening in the patient-reported physical impact of MS (≥7.5 point worsening from baseline to week 96 in the MSIS-29 physical score) compared to AVONEX.