The anti-inflammatory medication Zeposia (ozanimod) is under review in the European Union as a treatment for adults with moderately to severely active ulcerative colitis.
The European Medicines Agency has validated an application from Bristol Myers Squibb (BMS) seeking Zeposia’s approval, and will now begin its centralized review process.
“This validation is an important step toward making Zeposia available to eligible patients in the European Union, who are in need of new treatment options offering proven efficacy and safety, as well as oral administration,” Mary Beth Harler, MD, head of immunology and fibrosis development at BMS, said in a press release.
Ulcerative colitis, a form of inflammatory bowel disease (IBD), is characterized by increased inflammation in the digestive system, which is driven by immune cells called lymphocytes.
Zeposia works by targeting two receptor proteins, called sphingosine-1-phosphate (S1P)-1 and S1P-5. By targeting these receptors, Zeposia is thought to reduce the number of active lymphocytes circulating in the digestive system, thus lessening inflammation and, by extension, disease symptoms.
The marketing authorization application for Zeposia was based on results from a Phase 3 clinical trial called True North (NCT02435992). The trial enrolled people with moderate to severe ulcerative colitis who had not adequately responded to prior treatment.
The trial was conducted in two phases: in the induction phase, 645 participants were given either Zeposia or a placebo for 10 weeks. Participants who were in clinical remission after this initial phase were then randomized again to either Zeposia or a placebo in the maintenance phase of the trial, which lasted 52 weeks (about a year).
In both phases, significantly more participants on Zeposia than placebo achieved clinical remission, as assessed by colonoscopy — 18.4% vs. 6% in the placebo group in the induction phase, and 37% vs. 18.5% in the maintenance phase.
Zeposia also outperformed the placebo in the number of participants who responded to the treatment — 47.8% vs. 25.9% in the placebo group in the induction phase, and 60.0% vs. 41.0% in the maintenance phase.
No new safety concerns were identified in the True North trial.
Of the 457 participants who participated in the maintenance phase, 80% of participants on Zeposia and 54.6% of those on placebo completed the 52-week study. The most common reason for discontinuation was disease relapse (13.5% in the Zeposia group and 33.9% in the placebo group).
Participants who completed the trial were allowed to enroll in an open-label extension study (NCT02531126), which is evaluating the long-term safety and efficacy of Zeposia as a treatment for moderately to severely active ulcerative colitis. This long-term trial is expected to last up to six years.
Zeposia is also being investigated as a treatment for active Crohn’s disease, another form of IBD, in the ongoing Phase 3 YELLOWSTONE clinical trial program (NCT03467958).
The medication is approved in the U.S. to treat adults with relapsing multiple sclerosis. It is also approved in Europe for the treatment of active relapsing-remitting multiple sclerosis.
Zeposia was initially developed by Celgene, which was acquired by BMS last year. The therapy is not approved for the treatment of ulcerative colitis in any country.