Benzinga | Nov 23, 2021 11:46AM EST

Bristol Myers' Zeposia Wins European Approval For Ulcerative Colitis

The European Commission has approved Bristol Myers Squibb & Co's (NYSE:BMY) Zeposia (ozanimod) for ulcerative colitis (UC).

* 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.