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Psoriatic Arthritis News | FDA Approvals | EMA Approvals | PMDA Approvals | NMPA China Approvals

Updated: Jan 7, 2022

AbbVie's immunology portfolio in Europe is strengthened with Skyrizi approval for psoriatic arthritis

Approval is based on the trial results from KEEPsAKE-1 and KEEPsAKE-2

Skyrizi was evaluated in biologic naive and experienced patients

AbbVie announced that the European Commission approved Skyrizi for adult patients with psoriatic arthritis who are intolerant to one or more disease-modifying anti-rheumatic drugs.

The approval is based on the KEEPsAKE-1 and KEEPsAKE-2. Skyrizi has met the primary endpoint of ACR20 versus placebo; in addition to this, the drug has met secondary endpoints.

KEEPsAKE-1: 57.3% of patients met the primary endpoint versus 33.5% in the placebo arm; 2.5% of patients reported severe adverse events

KEEPsAKE-2: 51.3% of patients met the primary endpoint versus 26.5% in the placebo arm; 4.0% of patients reported severe adverse events

Tremfya was another IL-23 inhibitor approved for psoriatic arthritis in Europe. AbbVie's drug will face competition with Janssen's Tremfya for psoriatic arthritis.

Skyrizi was previously approved for psoriasis by the European Commission.



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