Florida Gastroenterological Society
Florida Gastroenterological Society

FDA accepts investigational NDA for ulcerative colitis therapy

The FDA accepted the investigational new drug application for ABX464 for the treatment of patients with moderate to severe ulcerative colitis, according to the drug’s manufacturer.Currently, researchers are assessing ABX464 (Abivax) across 15 European countries and in Canada in 232 patients with moderate to severe UC. This FDA clearance allows the phase 2b trial to extend into the United States.Recent phase 2a data demonstrated that 75% of patients who had previously failed other therapies were in clinical remission after receiving study drug.“I am pleased that this promising drugRead More

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