EU Reviewing Zeposia as Ulcerative Colitis Treatment for Adults

EU Reviewing Zeposia as Ulcerative Colitis Treatment for Adults
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
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