AbbVie Submits Regulatory Applications to the US FDA and EMA for Rinvoq (upadacitinib) to Treat Crohn's Disease
Shots:
- The applications were based on the three P-III trials, incl. (U-EXCEED & U-EXCEL) induction studies & (U-ENDURE) maintenance study to evaluate upadacitinib (45mg, qd) as IT & (15/30mg, qd) as MT vs PBO in adults with active CD
- The results showed that patients achieved the co-primary EPs of clinical remission & endoscopic response measured by the CDAI or by the patient-reported symptoms of SF/AP 1-4 in the induction & maintenance study, patients with (45mg, qd) @12wk. or (15/30mg, qd) @52wks. also achieved the 2EPs of corticosteroid-free clinical remission per CDAI & SF/AP
- The safety results were consistent with the known safety profile of upadacitinib with no new safety risks. Rinvoq is being evaluated in multiple immune-mediated inflammatory diseases
Ref: PRNewswire | Image: AbbVie
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