AbbVie’s Rinvoq (upadacitinib) Receives EC’s Approval for the Treatment of Moderately to Severely Active Crohn's Disease
- The approval was based on 3 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
- The results showed that more patients achieved the co-1EPs in the induction & maintenance study treated with Rinvoq 45mg @12wk. and (15 & 30mg) @52wks. demonstrated an endoscopic response (35% & 46% vs 4% & 13%) and (28% & 40% vs 7%); clinical remission (40% & 51% vs 14% & 22%) and (36% & 46% vs 14%), respectively
- In the 2EPs & additional EPs from the IT & MT, corticosteroid-free clinical remission (37% & 44% vs 7% & 13%) and (35% & 45% vs 14%); mucosal healing (17% & 25% vs 0% & 5%) and (13% & 24% vs 4%). The safety profile was consistent with the known safety profile of Rinvoq
Ref: AbbVie | Image: AbbVie
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