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# Rinvoq sNDA for Giant Cell Arteritis Filed
- URL: https://www.fdaweb.com/rinvoq-snda-for-giant-cell-arteritis-filed/
- Published: 2024-07-12T12:00:00.000Z
- Updated: 2026-09-14T14:35:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157342

AbbVie has filed a supplemental NDA for Rinvoq and its use in treating adult patients with giant cell arteritis (GCA), an autoimmune disease involving medium and large arteries that can cause headache, jaw pain, and changes in vision, including sudden and permanent loss of vision.

The submission is based on data from the Phase 3 SELECT-GCA study that showed upadacitinib 15 mg with a 26-week steroid taper regimen achieved the primary endpoint of sustained remission from Week 12 through Week 52, according to the company. The drug’s safety profile in patients with GCA was generally consistent with other approved indications, it adds.

AbbVie says the JAK inhibitor is also being studied in several other immune-mediated inflammatory diseases, such as alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.