![]() ![]() ![]() 1-4 Across all three studies, significantly more patients treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response, with clinical remission measured by the Crohn's Disease Activity Index (CDAI) or by the patient-reported symptoms of stool frequency/abdominal pain (SF/AP). The applications to the FDA and EMA are supported by data from three Phase 3 clinical trials, including two induction studies (U-EXCEED & U-EXCEL) and one maintenance study (U-ENDURE). "Those patients who are still suffering fuel our continued commitment to innovation in care for patients with IBD, and we look forward to potentially introducing a new treatment option for this disruptive condition." "Crohn's disease can be debilitating and have a significant impact on a person's daily life," said Neil Gallagher, M.D., Ph.D., vice president, development, chief medical officer, AbbVie. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ ®, 45 mg and 15 mg and 30 mg ) for the treatment of adult patients with moderately to severely active Crohn's disease. NORTH CHICAGO, Ill., J/PRNewswire/ - AbbVie (NYSE: ABBV) today announced that it has submitted applications for a new indication to the U.S. Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain 9,10.Safety results were generally consistent with the known safety profile of upadacitinib, with no new safety risks observed 1-8.Submissions are supported by three Phase 3 clinical trials demonstrating upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response as induction and maintenance treatment 1-4. ![]()
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