BMS’ Sotyktu secures EC approval for psoriatic arthritis

The approval is intended for adults with PsA who have had inadequate response or intolerance to previous disease-modifying antirheumatic drug (DMARD) therapy. Sotyktu can be used alone or with methotrexate.

This marks the first approval in the European Union for a tyrosine kinase 2 (TYK2) inhibitor in this indication.

The decision was based on results from the POETYK PsA-1 and POETYK PsA-2 Phase III clinical trials.

Both trials assessed the efficacy and safety of 6mg Sotyktu once daily in adults with active PsA.

Participants treated with Sotyktu showed significant improvement in disease activity, as measured by American College of Rheumatology (ACR) 20 response and Minimal Disease Activity (MDA), compared to placebo.

Safety findings for Sotyktu were generally consistent with those observed in plaque psoriasis.

Adverse reactions (≥1%) included increased blood creatine phosphokinase, upper respiratory infections, oral ulcers, herpes simplex infections, folliculitis, and acneiform rash.

The Phase III programme studied adults with active PsA in the multicentre, randomised, double-blind, placebo-controlled trials.

Sotyktu had previously been approved by the US Food and Drug Administration (FDA) for PsA in March 2026.

BMS cardiovascular and immunology commercialisation senior vice-president Al Reba said: “The European approval of Sotyktu for active psoriatic arthritis represents an important advancement in addressing both the skin and joint symptoms of this chronic immune-mediated disease.

“This milestone marks a new approach to treating psoriatic arthritis, and we look forward to continuing the development of Sotyktu for other serious rheumatic conditions as part of our commitment to addressing the life-altering impact of these diseases.”

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