Bristol Myers Squibb (BMS) has announced that the European Commission (EC) has approved Sotyktu (deucravacitinib) for the treatment of active psoriatic arthritis (PsA) in adults. The drug is cleared for use either alone or in combination with methotrexate for patients who have had an inadequate response or intolerance to prior disease-modifying antirheumatic (DMARD) therapies.
Breakthrough in TYK2 inhibition Sotyktu is a once-daily oral, selective tyrosine kinase 2 (TYK2) inhibitor.
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Historical Milestone: It is the first TYK2 inhibitor to receive EU approval for active PsA. This follows a similar approval by the U.S. FDA in March 2026.
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Approval History: The drug was previously cleared in the U.S. (2022) and the EU (2023) for the treatment of moderate to severe plaque psoriasis.
Scientific Evidence and Efficacy The EU approval was based on positive results from two pivotal Phase III clinical trials (POETYK PsA-1 and POETYK PsA-2):
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Multifaceted Improvement: Patients treated with a 6-mg daily dose showed significant reductions in disease activity, addressing both musculoskeletal symptoms and skin/nail lesions.
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Quality of Life: Treatment resulted in meaningful improvements in health-related quality of life for patients.
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Safety Profile: The overall safety remained consistent with previously established data in patients with plaque psoriasis.
Strategic Vision Psoriatic arthritis is a chronic immune-mediated disease affecting up to 30% of people with psoriasis. BMS leadership emphasized that this milestone marks a new approach to treating PsA, and the company looks forward to expanding Sotyktu’s development into other serious rheumatic conditions.