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Ulcerative colitis is a chronic inflammatory bowel disease in which the large intestine (colon) becomes inflamed and ulcers (with dents or decay), leading to multiple onsets characterized by bloody diarrhea, abdominal cramps and fever.
risk of colon cancer is higher in patients with ulcerative colitis than in people without ulcerative colitis.
Myers Squibb announced today that the European Medicines Agency (EMA) has approved its Zeposia (ozanimod) sales authorization application (MAA) for the treatment of moderate to severe active ulcerative colitis (UC).
MAA presented to the EMA is based on the results of the True North study, a critical, placebo-controlled Phase III clinical trial designed to evaluate Zeposia as an induction and maintenance therapy for moderate to severe active UC.
True North reached two main endpoints, and compared to placebos, zeposia patients achieved statistically significant clinical remissions in the 10th week of induction and the 52nd week of maintenance.
Mary Beth Harler, director of immunology and fibrosis development at Bristol Myers Squibb, said: "Ulcerative colitis is an unpredictable disease that can be debilitating and many patients use different treatments when trying to control the disease."
