Shots:
- The approval is based on KEEPsAKE-1 & 2 studies to evaluate Skyrizi (150mg) vs PBO in patients with active PsA who had an inadequate response or were intolerant to biologic therapy & & DMARDs
- The trials meet its 1EPs i.e., patients achieved ACR20 response @24wks. (57.3% & 51.3%) vs (33.5% & 26.5%). The 2EPs includes improvements in clinical manifestations i.e., physical function as measured by HAQ-DI @24wks., patients achieved MDA (25.0% & 25.6%) vs (10.2% & 11.4%) & the safety profile was consistent with safety profile of Skyrizi in PsO
- The approval marks 2nd indication for Skyrizi. The MAA will be valid in all member states of the EU, Iceland, Liechtenstein, Norway & Northern Ireland
Click here to read the full press release/ article | Ref: AbbVie | Image: Wall Street Journal
The post AbbVie’s Skyrizi (risankizumab) Receives EC’s Approval for the Treatment of Active Psoriatic Arthritis first appeared on PharmaShots.
