The approval was based on the P-III trials (POETYK PSO-1 & 2) evaluating Sotyktu (6mg, qd) vs PBO and Otezla in 666 & 1020 patients which showed superior efficacy in improving skin clearance @16 & 24wks. with responses maintained through 52wks.
In both trials & time points, patients achieved an sPGA score of 0/1, PASI 75 & PASI 90 response while responses persisted through 52wk., 82% maintained their response at 52wk. in (POETYK PSO-1) trial who achieved PASI 75 at 24wk. while 80% who continued Sotyktu maintained PASI 75 response over 31% withdrew from Sotyktu in the (POETYK PSO-2) trial
The (POETYK PSO) LTE trial’s additional data also supported approval. The (POETYK) study program demonstrated a consistent safety profile at 3yrs. of continuous treatment
Ref: Businesswire | Image: BMS
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