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EU Approves New Psoriatic Arthritis Drug
11 May
Summary
- Sotyktu is now approved for adults with psoriatic arthritis in the EU.
- The drug is a first-in-class TYK2 inhibitor for this indication.
- Clinical trials showed significant improvements in disease activity.
The European Commission has granted approval for Bristol Myers Squibb's Sotyktu (deucravacitinib) to treat active psoriatic arthritis in adults. This approval is for patients who have shown an inadequate response or intolerance to prior disease-modifying antirheumatic drug therapies and can be administered alone or with methotrexate.
This milestone signifies the first approval in the European Union for a tyrosine kinase 2 (TYK2) inhibitor for this specific condition. The decision was informed by the positive outcomes of the POETYK PsA-1 and POETYK PsA-2 Phase III clinical trials, which demonstrated significant improvements in disease activity for patients treated with Sotyktu compared to placebo. Safety findings were consistent with previous observations.
