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