Shots:

• The opinion was based on the P-III KEEPsAKE-1 & 2 studies evaluate Skyrizi (150mg- SC) vs PBO in adults with active PsA who had an inadequate response or were intolerant to biologic therapy & non-biologic DMARDs
• The trial met its 1EPs of ACR20 response @24wks. The 2EPs also met that include improvements in clinical manifestations of PsA i.e.- skin clearance- 90% improvement in PASI 90- physical function as measured by HAQ-DI & MDA @24wks.- efficacy & safety profile was consistent with the profile observed ~24wks.
• If approved by the EC- therapy will mark the 2^nd indication in the EU. The MAA will be valid in all member states of the EU- Iceland- Liechtenstein- Norway & Northern Ireland

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