Bristol Myers Squibb Announces FDA Approval of Zeposia (ozanimod) for Moderately to Severely Active Ulcerative Colitis

Bristol-Myers Squibb (BMS) announced today that the U.S. FDA approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC). The press release noted that this is the first oral S1P receptor modulator approved for the treatment of patients with moderately to severely active UC.

This approval is based on the results of the pivotal Phase 3 clinical trial, True North. Compared with placebo, Zeposia significantly increased the proportion of patients achieving clinical remission at Week 10 of the induction period (18.4% vs. 6.0%; p<0.0001) and at Week 52 of the maintenance period (37.0% vs. 18.5%; p<0.0001), meeting the primary endpoint of the trial. Additionally, Zeposia met several key secondary endpoints, including clinical response, endoscopic improvement, and endoscopic-histologic mucosal improvement.

Ulcerative colitis is a chronic inflammatory bowel disease (IBD) characterized by a prolonged, abnormal immune response that results in persistent inflammation and ulceration of the colonic or rectal mucosa. Symptoms include bloody stools, severe diarrhea, and frequent abdominal pain. Ulcerative colitis has a significant impact on patients' health-related quality of life, affecting physical functioning, social and emotional well-being, and work ability. Many patients exhibit an inadequate response or no response to currently available treatments.

Zeposia (ozanimod) is an oral S1P receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia reduces the ability of lymphocytes to egress from lymph nodes, thereby decreasing the number of circulating lymphocytes in peripheral blood. It has received FDA approval for the treatment of multiple sclerosis. The mechanism by which Zeposia treats ulcerative colitis has not yet been fully elucidated, but may involve reducing the number of lymphocytes migrating into the inflamed intestinal mucosa.

Note: The original text has been abridged.

References:

[1] U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis. Retrieved May 27, 2021, from https://www.businesswire.com/news/home/20210527005878/en

▽Follow【WuXi AppTecGermany】WeChat Official Account