AbbVie’s Rinvoq (upadacitinib) Receives the US FDA’s Approval for the Treatment of Adults with Moderately to Severely Active Crohn's Disease
Shots:
- 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
- The results showed that more patients achieved the co-1EPs in both studies treated with Rinvoq 45mg @12wk. and (15 & 30mg) @52wks. demonstrated an endoscopic response (34% & 46% vs 3% & 13%) in 2 induction studies & (28% & 41% vs 7%) in the maintenance study; clinical remission (36% & 46% vs 18% & 23%) & (42% & 55% vs 14%), respectively
- In the 2EPs from the IT & MT, corticosteroid-free clinical remission (30% & 40% vs 11% & 13%) & (42% & 53% vs 14%), a greater proportion of patients achieved clinical response @2wk. The safety profile was consistent with the known safety profile of Rinvoq
Ref: AbbVie | Image: AbbVie
Related News:- AbbVie’s Rinvoq (upadacitinib) Receives EC’s Approval for the Treatment of Moderately to Severely Active Crohn's Disease
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
