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On May 27, US Eastern Time, BMS (Bristol-Myers Squibb) announced that the FDA approved 0.
The approval is based on the results of a pivotal Phase III clinical trial (TrueNorth).
During the 10-week induction therapy, compared with the placebo group (n=216), the clinical remission rate of the ozanimod group (n=429) was significantly increased (18.
During the 52-week maintenance treatment, compared with the placebo group (n=227), the clinical remission of the ozanimod group (n=230) was significantly improved (37% VS 19%; p<0.
ozanimod is the third S1P modulator approved by the FDA for marketing.
At present, the FDA has approved 4 S1P regulators to be listed, namely BMS’s ozanimod (acquired from Xinji, sales in 2020: 12 million US dollars), Johnson & Johnson ponesimod (approved for marketing in March 2021), and Novartis’s siponimod (3, 2019).
The FDA's approval of ozanimod for the treatment of UC can be said to open another major area for S1P modulators.
Both UC and CD belong to IBD (Inflammatory bowel disease, inflammatory bowel disease).
IBD affects 5 million people worldwide, and the prevalence has been increasing.
At present, there is no cure for IBD.
IBD is a debilitating disease that has a significant impact on the quality of life, requiring life-long treatment, and ultimately a considerable number of patients undergoing surgical treatment.
According to the report of Grand Viewer Search, the overall market size of IBD was US$15.
Global Data predicts that the CD market size will reach US$13.
The Reports and Data report predicts that the UC market will reach US$9.