Shots:
- The US FDA has approved Rinvoq (15mg; QD) to treat adults with giant cell arteritis (GCA) following the EC’s Approval in Apr 2025
- Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in 1st study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO + 52wk. CS taper regimen; Ongoing 2nd period will evaluate safety & efficacy of continuing vs withdrawing Rinvoq in pts, who achieved sustained remission in 1st period
- Trial met its 1EP, with 15mg Rinvoq achieving sustained remission in 46.4% vs 29% pts
Ref: AbbVie | Image: AbbVie
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