FDA Expands Approval to AbbVie’s Rinvoq for Ankylosing Spondylitis

The FDA has approved AbbVie’s oral Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib), for the treatment of adult patients with active ankylosing spondylitis, a form of arthritis that mainly affects the spine.

The approval was for patients who have previously shown an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

The new approval was supported by positive data from two pivotal studies in which patients showed significant improvement in the disease over those who received a placebo.

Rinvoq was previously approved by the agency for several other indications, including the treatment of moderate-to-severe rheumatoid arthritis, psoriatic arthritis and moderate-to-severe ulcerative colitis.