FDA Approves Updated Label for Psoriasis Drug
The FDA has approved a label update for Taltz (ixekizumab) injection 80 mg/mL to include data on psoriasis involving the genital area, making it the first and only treatment approved by the FDA for moderate-to-severe plaque psoriasis that includes such data.
The update is based upon positive results from a randomized, double-blind, placebo-controlled study in moderate-to-severe psoriasis involving the genital area which involved 149 patients with plaque psoriasis who were candidates for phototherapy or systemic therapy but failed to respond to or were intolerant to at least 1 topical therapy.
Overall, Taltz was associated with significant improvement compared with placebo at 12 weeks in the severity of psoriasisi affecting the genital area, overall psoriasis, genital itch, and patient-perceived impact of psoriasis on frequency of sexual activity.
Taltz was first approved in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Lilly's Taltz® (ixekizumab) Receives the First U.S. FDA approval for label update to include data for psoriasis involving the genital area [press release]. May 22, 2018. Indianapolis, Indiana. https://www.prnewswire.com/news-releases/lillys-taltz-ixekizumab-receives-the-first-us-fda-approval-for-label-update-to-include-data-for-psoriasis-involving-the-genital-area-300652329.html.