05.22.18
Eli Lilly and Co. received approval from the FDA for a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area. Taltz is the first and only treatment approved by the FDA for moderate-to-severe plaque psoriasis that includes such data in its label. Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In December 2017, Taltz was also approved for the treatment of adults with active psoriatic arthritis.
The label update is based on positive results from the first randomized, double-blind, placebo-controlled study in moderate-to-severe psoriasis involving the genital area. In the study, 149 patients with plaque psoriasis were treated with Taltz or placebo. Taltz demonstrated a significant improvement compared to placebo at 12 weeks in the severity of psoriasis affecting the genital area.
"Up to 63 percent of psoriasis patients will be impacted by psoriasis involving the genital area over the course of their disease," said Pete Salzmann, vice president, Lilly Immunology. "However, there remains a serious unmet need for patients seeking treatment options. We are proud of this important milestone for Taltz, and remain committed to pursuing research that may improve outcomes for people living with this challenging disease."
The label update is based on positive results from the first randomized, double-blind, placebo-controlled study in moderate-to-severe psoriasis involving the genital area. In the study, 149 patients with plaque psoriasis were treated with Taltz or placebo. Taltz demonstrated a significant improvement compared to placebo at 12 weeks in the severity of psoriasis affecting the genital area.
"Up to 63 percent of psoriasis patients will be impacted by psoriasis involving the genital area over the course of their disease," said Pete Salzmann, vice president, Lilly Immunology. "However, there remains a serious unmet need for patients seeking treatment options. We are proud of this important milestone for Taltz, and remain committed to pursuing research that may improve outcomes for people living with this challenging disease."