FDA approves Rinvoq for new Crohn's disease indication

The US Food and Drug Administration (FDA) yesterday approved Rinvoq (upadacitinib) for adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.

Developed by US pharma major AbbVie’s (NYSE: ABBV), Rinvoq is the first approved oral product available to treat moderately to severely active Crohn’s disease in the USA, and the FDA nod adds to the European Commission approval of the drug in this indication last month.

It also marks the seventh indication of Rinvoq, sales of which reached $686 million in the first quarter of 2023, with AbbVie forecasting sales of $7.5 billion by 2025.