The CHMP Adopts Positive Opinion for AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults
Shots:
- The CHMP has recommended Rinvoq (15mg; QD) for the treatment of Giant Cell Arteritis (GCA) in adults with the EC’s decision expected in H1’25
- Opinion was based on P-III (SELECT-GCA) trial assessing safety & efficacy of Rinvoq, where GCA pts (≥50yrs.) in first study period received either Rinvoq (7.5/15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO + 52wk. CS taper regimen
- Study met its 1EP of sustained remission (No GCA signs from wks. 12–52 & adherence to CS regimen) as well as its 2EPs of reduced disease flares, decreased cumulative steroid exposure, & complete remission (No GCA signs, normalized ESR & hsCRP levels from wks. 12–52, plus adherence to CS regimen)
Ref: AbbVie | Image: AbbVie
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