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AbbVie: SKYRIZI Gets EU Approval To Treat Adults With Active Psoriatic Arthritis

AbbVie (ABBV) announced that the European Union's European Commission has approved SKYRIZI (risankizumab) for the treatment of adults with active psoriatic arthritis.

Psoriatic arthritis is a systemic inflammatory disease that impacts the skin and joints, affecting approximately 30 percent of patients with psoriasis.

The EC approval was based on data from two Phase 3 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.

The company noted that it is the second indication for SKYRIZI, and the Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

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