The EMA’s CHMP adopted the positive opinion recommending the approval of upadacitinib for moderately to severely active CD
The opinion was based on 2 induction studies (U-EXCEED & U-EXCEL) & 1 maintenance study (U-ENDURE) evaluating upadacitinib (45mg, qd) as IT & 15/30mg, qd as MT vs PBO. In all P-III studies, patients achieved the co-primary EPs of clinical remission per SF/AP & endoscopic response
Patients also achieved the 2EPs of endoscopic remission, SES-CD ulcerated surface subscore of 0 @12 & 52wks. in patients with SES-CD ulcerated surface subscore ≥1 at baseline, mucosal healing is connected to improvements seen by endoscopy & absence or disappearance of ulceration. The safety profile was consistent with the known safety profile of upadacitinib
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