Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- May 11
- 2 min read
08/05/2026
BMS received EU approval of deucravacitinib for the treatment of active PsA in adults (Ref)
BMS announced that the European Commission had granted approval to Sotyktu (deucravacitinib; TYK2 inhibitor), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adults who had an inadequate response or had been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy.
The EU approval was 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 ACR 20 (the primary endpoint) and Minimal Disease Activity (key secondary endpoint).
The overall safety profile of Sotyktu observed in individuals with active PsA was generally consistent with the safety profile in those with plaque psoriasis.
Argenx announced US approval expanding VYVGART and VYVGART Hytrulo for use in all adult patinets living with gMG (Ref)
Argenx SE announced the US FDA had approved a label expansion for VYVGART® (efgartigimod alfa-fcab) and VYVGART Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG).
The approved sBLA expanded VYVGART’s indication to include all serotypes of adult patients living with gMG: anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
The approval was based on data from the Phase 3, ADAPT SERON study.
Patients treated with VYVGART in the Phase 3 study experienced rapid, significant and sustained symptom improvements that continued with ongoing treatment.
