J&J: FDA approves Tremfya for ulcerative colitis

(CercleFinance.com) - Johnson & Johnson has announced that the US FDA has approved its Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the large intestine in which the lining of the colon becomes inflamed.


Treatment with Tremfya resulted in significant improvement of chronic ulcerative colitis symptoms and, most importantly, normalization of the endoscopic appearance of the intestinal mucosa, the Center for Inflammatory Bowel Disease, University of Chicago Medicine, and principal investigator of the program said.

Approval is based on data from a pivotal Phase 2b/3 study.


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