Shots:

• The approval is based on a P-III True North trial assess Zeposia (0.92 mg) vs PBO in an adult with mod. to sev. active UC
• The trial met its 1EPs & 2EPs i.e Zeposia as an induction & maintenance therapy demonstrates clinical remission (18% vs 6% & 37% vs 19%)- clinical response (48% vs 26% & 60% vs 41%)- endoscopic improvement (27% vs 12% & 46% vs 26%)- endoscopic-histologic mucosal improvement (13% vs 4% & 30% vs 14%) @10 & 52 wks. respectively. Reduction in rectal bleeding & stool frequency subscores observed @2wks.
• The MAA for the therapy is currently under EMA review with the expected regulatory decision in H2’21. The Zeposia 360 Support program will care for patients with UC

  Ref: BMS | Image: BMS