FDA Approves AbbVie’s Rinvoq for Ulcerative Colitis

The FDA has expanded its approval for AbbVie’s blockbuster Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib), to include adults with moderate-to-severe ulcerative colitis who have had an inadequate response to tumor necrosis factor blockers.

The approval was supported by positive results from three phase 3 trials that all achieved their primary endpoints of clinical remission.

Other FDA-approved indications for Rinvoq include rheumatoid arthritis, psoriatic arthritis and atopic dermatitis.

The drug earned almost $1.7 billion last year and AbbVie projects that it will bring in more than $7.5 billion in global sales by 2025.