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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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