Shots:
- FDA has approved BMS‘ Sotyktu (6mg, PO, QD) ± methotrexate for adults with active PsA who have had an inadequate response or were intolerant to a prior disease-modifying antirheumatic (DMARD) therapy
- Approval was based on P-III trials, incl. POETYK PsA-1, involving 670 bDMARD-naïve pts, and POETYK PsA-2, involving 624 pts who were bDMARD-naïve & treated with prior TNFα inhibitor
- Both trials met the 1EP of ACR20 and 2EP of MDA, with Sotyktu showing improved SF-36 Physical Component Summary scores vs PBO at Wk. 16. QoL benefits were sustained through Wk. 52 across both POETYK PsA trials
Ref: Businesswire | Image: BMS | Press Release
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