AbbVie Submits Application to US FDA and EMA for Rinvoq (upadacitinib) to Treat Non-Radiographic Axial Spondyloarthritis
Shots:
- The application is based on the P-III (SELECT-AXIS 2/Study 2) trial to evaluate upadacitinib (15mg, qd) vs PBO in adult patients with nr-axSpA who have responded inadequately to NSAIDs
- The trial met its 1EPs & 2EPs i.e., patients treated with upadacitinib showed a reduction in signs & symptoms including back pain & inflammation along with improvements in physical function & disease activity @14wks., safety data were consistent with the known safety profile of upadacitinib & no new safety risks were identified
- The company has requested label enhancements for upadacitinib in the EU for AS, based on the results from the P-III (SELECT-AXIS 2/ Study 1) & P-II/III (SELECT-AXIS 1) trial
Ref: AbbVie | Image:abbvie
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