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The EC Approves AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Shots:

  • The EC has approved Rinvoq (15mg; QD) to treat adults with giant cell arteritis (GCA) in 30 EEA states
  • Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in first study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO + 52wk. CS taper regimen
  • 15mg dose achieved the 1EP with sustained remission in 46.4% vs 29% pts, & 2EPs showed sustained complete remission in 37.1% vs 16.1%, at least 1 disease flare in 34.3% vs 55.6% at Wk. 52, & lower cumulative steroid exposure (median exposure: 1615 vs 2882mg); data was published in The NEJM

Ref: AbbVie | Image: AbbVie

Related News:- AbbVie Reports P-III (MIRASOL) Trial Data of Elahere for FRα-Positive Platinum-Resistant Ovarian Cancer (PROC)

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