Bristol Myers Squibb (BMS)’s Sotyktu (deucravacitinib) has European Union (EU) approval for treatment of active psoriatic arthritis (PsA) in adults. The European Commission cleared the use of Sotyktu either alone or in combination with methotrexate. Eligible patients should have had a previous poor response or been unable to tolerate a prior disease-modifying antirheumatic (DMARD) therapy.

History of Sotyktu Approvals

Sotyktu is a once daily oral, selective tyrosine kinase 2 (TYK2) inhibitor. As such, it is the first TYK2 inhibitor to gain EU approval for treatment of active PsA. The U.S. FDA gave approval to Sotyktu for the same indication in March 2026. The drug was cleared in the U.S. in 2022—and the EC in 2023—for treatment of moderate to severe plaque psoriasis.

PsA is a chronic, immune-mediated, heterogeneous disease that results in multiple musculoskeletal and skin-related symptoms. These may include inflammatory arthritis, enthesitis, dactylitis, or psoriatic skin and nail lesions. As many as 30% of patients who have psoriasis develop PsA—which also carries the risk of serious comorbidities.

EU Backs BMS Approval With Trial Results

EU based its latest approval on positive results from two pivotal Phase III clinical trials (POETYK PsA-1, POETYK PsA-2). These judged safety and efficacy of Sotyktu in 6-mg daily doses. In both trials, treatment resulted in significant improvement in disease activity. Patients also displayed improvements in health-related quality of life. The overall safety profile was comparably consistent in individuals with active PsA as in those with plaque psoriasis.

BMS Senior Vice President, Cardiovascular & Immunology Commercialization Al Reba said Sotyktu addresses active PsA’s skin and joint symptoms.

“This milestone marks a new approach to treating psoriatic arthritis,” Reba said. “We look forward to continuing the development of Sotyktu for other serious rheumatic conditions.”

“PsA presents differently from patient to patient,” said Frank Behrens, MD, Professor of Rheumatology, Immunology, and Inflammation Medicine, Goethe-University Hospital. “The impressive safety and efficacy profile observed in the pivotal POETYK PsA trials demonstrate the [capabilities] of Sotyktu.”