FDA accepts sNDA for Zeposia in ulcerative colitis.- BMS

Bristol Myers Squibb announced that the FDA has accepted its supplemental New Drug Application (sNDA) for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC). Following the redemption of a Priority Review Voucher with the submission, the FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2021. The sNDA submitted to the FDA is based on results from True North, a pivotal, placebo-controlled Phase III trial evaluating Zeposia as an induction and maintenance therapy in adults with moderately to severely active UC. True North met both primary endpoints, demonstrating highly statistically significant and clinically meaningful results for clinical remission compared to placebo at induction at Week 10 and in maintenance at Week 52. The overall safety observed in True North was consistent with the known safety profile for Zeposia in approved labeling. For the maintenance phase, patients on Zeposia from either Cohort 1 or 2 who achieved clinical response in the induction phase at Week 10 were re-randomized 1:1 to Zeposia (n=230)or placebo (n=227) through Week 52. Of these, 80% and 54.6% of patients who received Zeposia and placebo, respectively, completed the study. Patients discontinuing treatment due to treatment-emergent adverse events included 3 patients receiving Zeposia and 6 patients receiving placebo; disease relapse (13.5% Zeposia, 33.9% placebo) was the most common reason for discontinuation. Patients on placebo who achieved clinical response in the induction phase at Week 10 remained on placebo during this blinded maintenance phase.