Shots:

• The approval was based on a P-III True North trial evaluates Zeposia vs PBO in a ratio (2:1) in 645 patients with UC who had an inadequate response or were intolerant to conventional therapy or a biologic agent
• The trial met its 1EPs i.e., Zeposia as an induction & maintenance therapy showed clinical remission (18% vs 6%) & (37% vs 19%), clinical response (48% vs 26%) & (60% vs 41%), improvement in endoscopic (27% vs 12%) & (46% vs 26%), endoscopic-histologic mucosal (13% vs 4%) & (30% vs 14%) @10 & 52wks., corticosteroid-free clinical remission (32% vs 17%) in maintenance @52wks.
• The safety profile was consistent with a safety profile for Zeposia & no new safety signals observed

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Ref: BMS | Image: BMS