Regulatory applications to FDA and EMA for upadacitinib in Crohn's disease submitted
AbbVie has announced that it has submitted applications for a new indication to the FDA and European Medicines Agency (EMA) for upadacitinib (Rinvoq, 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for the treatment of adult patients with moderately to severely active Crohn's disease
The applications to the FDA and EMA are supported by data from three Phase III clinical trials, including two induction studies (U-EXCEED & U-EXCEL) and one maintenance study (U-ENDURE). 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).
Additionally, more patients receiving upadacitinib 45 mg once daily at week 12 in the induction studies or 15 mg and 30 mg once daily at 52 weeks in the maintenance study achieved the secondary endpoint of corticosteroid-free clinical remission per CDAI and per SF/AP compared to placebo among patients taking corticosteroids at baseline.
The safety results of upadacitinib in U-EXCEED, U-EXCEL and U-ENDURE were generally consistent with the known safety profile of upadacitinib, with no new safety risks observed.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.