Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
Biosimilars Deals 2023
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Trade Marks

CHMP gives positive opinion for AbbVie’s RINVOQ® (upadacitinib)

Feb 27, 2023

AbbVie announced that the EMA CHMP recommended approval of RINVOQ® (upadacitinib) for treatment of moderate to severe Chron’s disease when patients have not responded to conventional therapy or biologic.  The CHMP relied on three phase III trials, including two induction studies, U-EXCEED and U-EXCEL, and one maintenance study, U-ENDURE.

The CHMP recommend expanding the indications for RINVOQ® (upadacitinib) to treatment of moderate to severe atopic dermatitis (in addition to rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis)  on 24 June 2021.  On 19 May 2022, CHMP recommended it be further expanded to include moderate to severe active ulcerative colitis.