AbbVie Receives EMA’s CHMP Positive Opinion of Rinvoq (upadacitinib) for Crohn's Disease

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AbbVie Receives EMA’s CHMP Positive Opinion of Rinvoq (upadacitinib) for Crohn's Disease


  • 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

Ref: AbbVie | Image: AbbVie

Related News:- AbbVie’s Rinvoq (upadacitinib) Receives NICE Recommendation for the Treatment of Active Ulcerative Colitis

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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.

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