15 October 2021 - CHMP positive opinion is based on data from two Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2.
AbbVie today announced the EMA's CHMP recommended the approval of risankizumab (Skyrizi, 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate, 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.