BMS Seeks FDA Approval for Zeposia in Ulcerative Colitis with May Decision Date

Key Insights

• Bristol-Myers Squibb has submitted Zeposia (ozanimod) for FDA review in treating moderate to severe ulcerative colitis, with a priority review decision expected by May 30.
• In clinical trials, Zeposia demonstrated significant efficacy with 18.4% of patients achieving clinical remission at 10 weeks compared to 6.8% on placebo, and 37% maintaining remission at one year.
• If approved, Zeposia would become the first S1P modulator for ulcerative colitis, potentially expanding BMS's market presence beyond its current multiple sclerosis indication.

Bristol-Myers Squibb has submitted its S1P receptor modulator Zeposia (ozanimod) to the FDA for the treatment of adults with moderately to severely active ulcerative colitis (UC). The agency has granted priority review status, with a decision expected by May 30th.

Clinical Trial Results Support Expansion

The submission is backed by compelling data from the True North trial, which demonstrated Zeposia's efficacy in treating ulcerative colitis. The study showed that 18.4% of patients achieved clinical remission after 10 weeks of treatment, compared to 6.8% in the placebo group. Long-term efficacy was also established, with 37% of treated patients maintaining remission at the one-year mark, versus 18.5% in the control arm.

Strategic Market Positioning

Zeposia, which received FDA approval for multiple sclerosis (MS) indications in 2020, would be entering the UC market at a crucial time. While the drug faces competition from established MS treatments like Novartis's Gilenya (fingolimod) and Mayzent (siponimod) in its current indication, it would be the first S1P modulator approved for UC treatment.

The UC therapeutic landscape currently includes various treatment options, such as TNF inhibitors and Johnson & Johnson's Stelara (ustekinumab), an IL-12/IL-23 blocker. Recent market entrants include AbbVie's JAK inhibitor Rinvoq (upadacitinib), which received FDA approval for UC last month.

Commercial Implications and Future Prospects

Despite a modest commercial start in MS due to pandemic-related challenges - with sales of just $2 million in the third quarter of 2020 - the UC indication could significantly boost Zeposia's market potential. Industry analysts had previously projected 2024 sales of $1.6 billion for the drug.

BMS is also exploring additional inflammatory bowel disease indications for Zeposia, including Crohn's disease. However, the company will need to monitor emerging competition, particularly from Arena Pharmaceuticals' etrasimod, another S1P modulator in late-stage development for UC.