Sun Pharmaceutical announced that the Food and Drug Administration (FDA) has approved Ilumya (tildrakizumab-asmn) injection for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The new approval was supported by data from the Phase 3 reSURFACE clinical program (reSURFACE1 and reSURFACE2; N=926). Part 1 of the studies randomized patients into 3 or 4 treatments arms: Ilumya 100mg, Ilumya 200mg, placebo, and etanercept (reSURFACE 2 only). After 12 weeks, patients receiving placebo were re-randomized to Ilumya 100mg and 200mg treatment arms to enter part 2. Then in Part 3 of reSURFACE 1, responders and partial responders to Ilumya were re-randomized after Week 28 to continue the same treatment, a different Ilumya dose, or placebo; partial and non-responders to etanercept were administered Ilumya 200mg in part 3 of reSURFACE 2.
Both studies achieved the primary efficacy endpoints as measured by significant clinical improvement in the Psoriasis Area Sensitivity Index (PASI 75) and Physician’s Global Assessment (PGA) score of “clear” (0) or “minimal” (1) at Week 12 after 2 doses.
In reSURFACE 1, 58% of Ilumya-treated patients achieved PGA of 0 or 1 vs 7% of placebo patients. Compared to placebo, significantly more patients achieved PASI 75 (64% vs 6%), PASI 90 (35% vs 3%), and PASI 100 (14% vs 1%). In reSURFACE 2, 55% of Ilumya-treated patients achieved PGA of 0 or 1 vs 4% of placebo patients and 48% of etanercept-treated patients. Compared to placebo, significantly more patients achieved PASI 75 (61% vs 6%), PASI 90 (39% vs 1%), and PASI 100 (12% vs 0%).
Ilumya, an interleukin-23 antagonist, acts by selectively binding to to the p19 subunit of IL-23 and inhibiting its interaction with the IL-23 receptor, blocking the release of pro-inflammatory cytokines and chemokines.
Ilumya will be available as a 100mg/mL strength solution for subcutaneous injection in single-dose prefilled syringes.
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