BMS’ Sotyktu (deucravacitinib) Receives the US FDA’s Approval for the Treatment of Moderate-to-Severe Plaque Psoriasis
Shots:
- The approval was based on the P-III (POETYK PSO-1 & 2) trials evaluating Sotyktu (6mg, qd) vs PBO & Otezla (30mg, BID) in 1684 patients aged ≥18yrs. with PsO. The therapy will be available in the US in Sept 2022
- The results showed superior efficacy & patients achieved PASI 75/PASI 90/sPGA 0/1 in (POETYK PSO-1) trials @16 & 24wks. (58% & 69% in Sotyktu vs 13% in PBO and 35% & 38% in Otezla/36% & 42% vs 4% and 20% & 22%/54% & 59% vs 7% and 32% & 31%) while (53% & 58% vs 9% and 40% & 38%/27% & 32% vs 3% and 18% & 20%/50% & 49% vs 9% and 34% & 30%) in (POETYK PSO-2) trial
- In the (POETYK PSO-1) trial, responses persisted through 52wk. who achieved PASI 75 @24wk. (82%) while in (POETYK PSO-2) trial, 80% vs 31%, AEs lead to discontinuation (2.4% vs 3.8% & 5.2%)
Ref: BMS | Image: BMS
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