FDA Considering Pfizer’s Rheumatoid Arthritis Therapy Xeljanz for Ulcerative Colitis, Too

FDA Considering Pfizer’s Rheumatoid Arthritis Therapy Xeljanz for Ulcerative Colitis, Too
U.S. regulators are considering extending their approval of Pfizer's rheumatoid arthritis therapy Xeljanz to ulcerative colitis as well. That possibility surfaced when the Food and Drug Administration accepted Pfizer's supplemental New Drug Application for Xeljanz (tofacitinib citrate) as a treatment for adults with moderate to severe ulcerative colitis. The FDA requires a company to file a New Drug Application when it wants to market a new treatment in the United States. A supplemental application is a request to use the therapy for an additional disease. It usually includes information about the therapy's effectiveness against the other disease. That information can come from both clinical trials and preclinical-trial studies. Pfizer included the results of three Phase 3 clinical trials of Xeljanz in its supplemental application. The company named the trials OCTAVE, for Oral Clinical Trials for tofAcitinib in ulceratiVE colitis. The three studies were called OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain. Xeljanz eliminated ulcerative colitis in a significantly higher percentage of patients than those who received a placebo, researchers said. It also healed the intestinal linings of twice as many patients who took it by the eighth week of the OCTAVE Induction 1 trial — 31.3 percent, versus 15.6 percent of the placebo group. The therapy inhibits Janus kinases, enzymes that promote pro-inflammatory proteins involved in the development of autoimmune disea
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