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FDA Approves Updated Label for Psoriasis Drug

May 22, 2018

The FDA approved a label update for Taltz (ixekizumab; Lilly) injection 80 mg/mL to include data on psoriasis with genital area involvement. Taltz was first approved by the FDA in March 2016 for adults with moderate to severe plaque psoriasis who were candidates for systemic therapy or phototherapy and is the first and only therapy to include data on genital psoriasis on its label. 

The label update was based on data from a randomized, double-blind, placebo-controlled study that included 149 participants with plaque psoriasis with genital involvement who were candidates for phototherapy or systemic therapy and failed to respond to or were intolerant of at least 1 topical treatment. After 12 weeks, participants randomized to Taltz experienced significant improvements in psoriasis severity in the genital area, overall psoriasis, genital itch, and in patient-perceived impact of psoriasis involving the genital area on frequency of sexual activity compared with those randomized to placebo.

Common adverse events associated with Taltz included injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Patients who receive Taltz should be monitored for signs and symptoms of inflammatory bowel disease. Taltz is contraindicated for patients with hypersensitivity reactions to Taltz or any of its excipients.  

Taltz was approved in December 2017 for adults with active psoriatic arthritis.

Melissa Weiss

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