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

New indication alert: FDA approves AbbVie’s RINVOQ® (upadacitinib) as first oral treatment for moderately to severely active Chron’s disease

May 18, 2023

The FDA has approved AbbVie’s RINVOQ® (upadacitinib) for adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.  RINVOQ® is the first oral treatment approved to this indication.  The approval was based on efficacy and safety in two randomized induction trials NCT03345836 and NCT03345849. 

On the same day, the National Institute for Health and Care Excellence issued final draft guidance recommending Rinvoq® as an option for eligible adults with moderate to severe active CD on the NHS in England and Wales.