The European Commission has approved Sotyktu (deucravacitinib) for active psoriatic arthritis in adults, making Bristol Myers Squibb’s (NYSE: BMY) oral TYK2 inhibitor the first in its class to receive EU authorization for this indication.

The approval covers use of Sotyktu, administered once daily at 6 mg, alone or in combination with methotrexate, in adults with active psoriatic arthritis who have had an inadequate response or intolerance to prior disease-modifying antirheumatic drug (DMARD) therapy. The approval is supported by the EU Summary of Product Characteristics, which lists special warnings covering infections, tuberculosis screening, malignancies, major adverse cardiovascular events, deep venous thrombosis, pulmonary embolism, and immunization status.

The approval is based on data from the Phase III POETYK PsA-1 and POETYK PsA-2 trials, which evaluated deucravacitinib 6 mg once daily in adults with active psoriatic arthritis. The primary endpoint was ACR20 response at Week 16, with Minimal Disease Activity as a key secondary endpoint. Both trials met their primary endpoint, with Sotyktu demonstrating superiority over placebo across joint and skin measures, and improvements in SF-36 Physical Component Summary scores maintained through Week 52.

Competitive and scientific context

Sotyktu joins an established oral therapy segment in psoriatic arthritis that includes apremilast (Otezla, Amgen), a PDE4 inhibitor approved for the same post-DMARD population, and upadacitinib (Rinvoq, AbbVie), a selective JAK1 inhibitor with a near-identical EU indication. Deucravacitinib’s differentiation rests on its allosteric binding to the TYK2 pseudokinase domain, a mechanism that selectively modulates IL-23, IL-12, and type I interferon signaling without the broader JAK pathway inhibition associated with cardiovascular and thromboembolic warnings carried by JAK inhibitors. The EU approval follows a US FDA authorization for the same indication granted in March 2026, extending the drug’s geographic reach across its two largest markets.

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