Bristol Myers Squibb's Sotyktu Approved by EU for Psoriatic Arthritis

Bristol Myers Squibb announced that the European Commission has granted approval to Sotyktu, or deucravacitinib, alone or in combination with methotrexate, for the treatment of active psoriatic arthritis, or PsA, in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic therapy. Sotyktu, a once-daily oral, selective tyrosine kinase 2 inhibitor, is the first TYK2 inhibitor to be approved for the treatment of active PsA in the European Union. This EU approval is based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 clinical trials, which evaluated the efficacy and safety of Sotyktu 6 mg once daily in adults with active PsA. In both trials, treatment with Sotyktu resulted in significant improvement in disease activity, as measured by American College of Rheumatology 20 and Minimal Disease Activity. The overall safety profile of Sotyktu observed in individuals with active psoriatic arthritis was generally consistent with the safety profile in those with plaque psoriasis. The most common adverse reactions are upper respiratory infections, blood creatine phosphokinase increased, herpes simplex infections, oral ulcers, acneiform rash and folliculitis. Sotyktu is associated with the following special warnings and precautions for use: infections; pre-treatment evaluation for tuberculosis; malignancies; major adverse cardiovascular events, deep venous thrombosis and pulmonary embolism; immunizations; and excipients.