AbbVie Reports the Regulatory Submissions to the US FDA and EMA of Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis (GCA)
Shots:
- AbbVie has submitted regulatory applications to the US FDA & EMA seeking approval of Rinvoq (15mg, QD) to treat GCA adults, based on P-III (SELECT-GCA) trial data
- Trial determined the safety & efficacy of Rinvoq among GCA patients (n=428) in 2 periods with period 1 assessing Rinvoq + 26wk. corticosteroid taper regimen vs PBO + 52wk. corticosteroid taper regimen & period 2 assessing effects of continuing vs withdrawing Rinvoq in those with sustained remission in period 1
- Study met its 1EP showing sustained remission in 46% vs 29% and 2EP depicting sustained complete remission in 37% vs 16% from wk.12 to wk.52 with at least 1 disease flare in 34% vs 56% at wk.52; Rinvoq (7.5mg) did not meet any of the EPs
Ref: AbbVie | Image: AbbVie
Related News:- AbbVie’s Tepkinly (Epcoritamab) Gains the CHMP’s Positive Opinion to Treat R/R Follicular Lymphoma
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
