Biopharmaceutical company Bristol Myers Squibb (NYSE:BMY) announced on Friday that the European Commission has approved Sotyktu (deucravacitinib), alone or with methotrexate, for adults with active psoriatic arthritis (PsA) who had an inadequate response or intolerance to prior disease-modifying antirheumatic therapy.

Bristol Myers Squibb said that Sotyktu is the first tyrosine kinase 2 (TYK2) inhibitor approved in the European Union for active PsA. It is administered as a once-daily oral treatment.

The approval was supported by results from the Phase 3 POETYK PsA-1 and POETYK PsA-2 trials, in which Sotyktu demonstrated significant improvement in disease activity versus placebo, including ACR20 and Minimal Disease Activity endpoints. Bristol Myers Squibb also reported improvements in skin and joint symptoms and quality-of-life measures through Week 16, with benefits maintained through Week 52.

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

Sotyktu received US FDA approval for active PsA in March 2026 and was initially approved by the US regulator in 2022 for moderate-to-severe plaque psoriasis (PsO).