The EMA’s CHMP has recommended the approval of Rinvoq (15mg, qd) for the treatment of active nr‑axSpA in adult patients with a clinical diagnosis of nr-axSpA who have responded inadequately to NSAIDs. The EC decision is expected in Q3’22
The application was based on the P-III (SELECT-AXIS 2) study evaluated the efficacy and safety of upadacitinib vs PBO in 314 patients with a clinical diagnosis of nr-axSpA. The study met the 1EPs of ASAS40 and the first 12 of 14 ranked 2EPs. The safety data were previously reported with no new risks compared to the known safety profile of upadacitinib
The EC’s decision will be valid in all member states of the EU, Iceland, Liechtenstein, Northern Ireland & Norway. Upadacitinib has been approved for use in the EU for mod. to sev. active RA, PsA, AS, and AD
Ref: PRNewswire | Image: AbbVie
