Eli Lilly announced that the Food and Drug Administration (FDA) has approved Taltz (ixekizumab) injection for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
The FDA approval was supported by data from a LARGE Phase 3 trial program (UNCOVER-1, UNCOVER-2, and UNCOVER-3) enrolling over 3,800 patients with moderate-to-severe plaque psoriasis across 21 countries. The program included patients who initiated the trial on Taltz or placebo or an active comparator (etanercept; Enbrel).
The co-primary efficacy endpoints at 12 weeks for all the studies were a 75% improvement in the composite Psoriasis Area Severity Index (PASI) score and static Physician’s Global Assessment (sPGA) 0 or 1 and at least a 2-point improvement from baseline.
At 12 weeks, 87–90% of patients treated with Taltz saw a significant improvement in their psoriasis plaques (PASI 75) and 81–83% of patients treated with Taltz achieved sPGA 0 or 1. Virtually clear skin (PASI 90) was achieved in 68–71% of patients treated with Taltz and 35–42% of patients saw complete resolution of their psoriasis plaques (PASI 100, sPGA 0). For those treated with placebo, ≤7% achieved PASI 75 or sPGA 0 or 1; ≤3% achieved PASI 90, and ≤1% achieved PASI 100 or sPGA 0.
Treatment with Taltz also demonstrated statistical superiority to etanercept at all skin clearance levels, including PASI 75 and sPGA 0 or 1 at 12 weeks. An integrated analysis of UNCOVER-2 and UNCOVER-3 showed that PASI 75 was achieved in 87% of Taltz-treated patients vs. 41% in placebo. Further, sPGA 0 or 1 was achieved in 73% vs. 27%.
Taltz is a humanized IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A), a protein involved in driving underlying inflammation in psoriasis. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.
Taltz injection will be available as an 80mg/mL strength single-dose autoinjector in 1-, 2-, and 3-count cartons as well as a single-dose prefilled syringe in 1-, 2-, and 3-count cartons. It is anticipated to launch in the second quarter of 2016.
For more information call (800) 545-5979 or visit Lilly.com.