Bristol-Myers Squibb (BMY) Application for Zeposia for Treatment of Ulcerative Colitis Accepted for Filing with Priority Review by FDA

February 1, 2021 7:10 AM EST

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Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (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.

“People living with ulcerative colitis often struggle to manage their disease and can face a severe impact to their lives, highlighting a need for new oral treatment options with proven safety and efficacy profiles that can be utilized early in the treatment journey,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “We look forward to continuing to work with the FDA to bring Zeposia to those living with this serious, chronic disease.”

The sNDA submitted to the FDA is based on results from True North, a pivotal, placebo-controlled Phase 3 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.

Bristol Myers Squibb thanks the patients and investigators who participated in the Zeposia Phase 3 UC True North clinical trial.

About True North

True North is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Zeposia 1 mg in patients with moderately to severely active ulcerative colitis who did not adequately respond to prior treatment. In the induction phase, a total of 645 patients were randomized to receive Zeposia (n=429) or placebo (n=216) in Cohort 1, of whom 94% and 89%, respectively, completed the induction period. At study entry, mean age was 42 years, 60% were male and mean disease duration was 7 years; patient characteristics were well-balanced across treatment groups. Cohort 1 patients were randomized 2:1 to Zeposia or placebo and treated once daily for 10 weeks. Cohort 2 (n=367) was an open-label arm where patients were treated once daily with Zeposia for 10 weeks.

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.

In Cohort 1 of the induction phase and in the re-randomized patient group in the maintenance phase, approximately 30% of patients had prior TNF-inhibitor exposure.

All eligible patients were rolled into 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.

The primary endpoints in True North are the proportion of patients in clinical remission based on a composite clinical and endoscopic score (3-component Mayo Score) at Week 10 in the induction phase, and at Week 52 in the maintenance phase. Secondary endpoints include the proportion of patients achieving clinical response at Week 10 and Week 52, the proportion of patients with endoscopic improvement (endoscopy score ≤1) at Week 10 and Week 52, the proportion of patients with mucosal healing at Week 10 and Week 52, and clinical remission at Week 52 in patients that were in remission at Week 10. In this study, mucosal healing is defined as endoscopic improvement with histologic remission. More information can be found on, NCT02435992.

About Ulcerative Colitis

Ulcerative colitis, a chronic inflammatory bowel disease (IBD), is characterized by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon) or rectum. Symptoms include bloody stools, severe diarrhea and frequent abdominal pain. Ulcerative colitis has a major impact on patients' health-related quality of life, including physical functioning, social and emotional well-being and ability to work. Many patients have an inadequate response or do not respond at all to currently available therapies. It is estimated that approximately 1.6 million people in the United States have IBD, which includes ulcerative colitis and Crohn's disease.

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