- The approval comes for adult patients with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
- Zeposia, an oral medication taken once daily, is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).
- The approval was based on data from the True North Phase 3 trial.
- During induction at Week 10 (Zeposia N=429 versus placebo N=216), the trial met its primary endpoint of clinical remission (18% versus 6%)
- During maintenance at Week 52 (Zeposia N=230 versus placebo N=227), the trial met its primary endpoint of clinical remission (37% versus 19%).
- In the induction and maintenance phases of the True North trial, the overall safety profile was consistent with the known safety profile for Zeposia.
- Related Link: Bristol-Myers’ Zeposia Scores FDA Approval For Ulcerative Colitis.
- Price Action: BMY shares are up 1.37% at $57.82 during the market session on the last check Tuesday.
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