Bristol Myers Squibb (NYSE: BMY) announced the European Commission has approved Sotyktu (deucravacitinib) for treating active psoriatic arthritis in adults who have had inadequate response or intolerance to prior disease-modifying antirheumatic drug therapy.

Sotyktu, a once-daily oral selective tyrosine kinase 2 inhibitor, can be used alone or in combination with methotrexate. The drug is the first TYK2 inhibitor approved for psoriatic arthritis treatment in the European Union.

The approval is based on results from two Phase 3 clinical trials, POETYK PsA-1 and POETYK PsA-2, which evaluated the drug's efficacy and safety in adults with active psoriatic arthritis. In both trials, Sotyktu 6 mg once daily demonstrated significant improvement in disease activity compared to placebo at Week 16.

In POETYK PsA-1, 54.2% of patients treated with Sotyktu achieved ACR20 response compared to 34.1% with placebo. In POETYK PsA-2, 54.2% achieved ACR20 response compared to 39.4% with placebo. Both trials also showed significant improvements in Minimal Disease Activity endpoints.

The most common adverse reactions include upper respiratory infections, increased blood creatine phosphokinase, herpes simplex infections, oral ulcers, acneiform rash and folliculitis. The safety profile was generally consistent with that observed in plaque psoriasis patients.

Sotyktu was previously approved by the U.S. FDA in March 2026 for active psoriatic arthritis treatment and has been approved since 2022 for moderate-to-severe plaque psoriasis in multiple countries.