BMS’ Zeposia (ozanimod) Receives the US FDA’s Approval for Ulcerative Colitis

May 28, 2021 Auto Bot approval, BMS, FDA, regulatory, Zeposia 0

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

Click here to­ read full press release/ article | Ref: BMS | Image: TAPinto

The post BMS’ Zeposia (ozanimod) Receives the US FDA’s Approval for Ulcerative Colitis first appeared on PharmaShots.