Bristol Myers Squibb Receives Positive CHMP Opinion for Zeposia (ozanimod) as a Treatment for Adult Patients with Moderately to Severely Active Ulcerative Colitis
The CHMP adopted this positive opinion based on data from True North, a pivotal Phase 3 trial evaluating Zeposia as an induction and maintenance therapy versus placebo in adult patients with moderately to severely active UC.
- The CHMP adopted this positive opinion based on data from True North, a pivotal Phase 3 trial evaluating Zeposia as an induction and maintenance therapy versus placebo in adult patients with moderately to severely active UC.
- The U.S. Food and Drug Administration approved Zeposia for the treatment of adults with moderately to severely active UC on May 27, 2021.
- Bristol Myers Squibb thanks the patients and investigators involved in the True North clinical trial.
- Bristol Myers Squibb is continuing to evaluate Zeposia in an open-label extension trial, which is ongoing and designed to assess the longer-term profile of Zeposia for the treatment of moderately to severely active ulcerative colitis.