European Commission approves Skyrizi to treat psoriatic arthritis.-AbbVie
The EC approval was based on data from two Phase III studies evaluating Skyrizi in psoriatic arthritis patients, KEEPsAKE-1 and KEEPsAKE-2. In these studies, SKYRIZI met the primary endpoint of ACR20 response at week 24 versus placebo. The approval is for Skyrizi (risankizumab, 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate or MTX, for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying anti-rheumatic drugs or DMARDs.
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