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FDA Updates Label for Taltz for Genital Psoriasis

PharmaLive news release; 2018 May 22

Eli Lilly and Company has announced that the US Food and Drug Administration (FDA) has approved a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area. 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. Eli Lilly and Company is headquartered in Indianapolis, IN.

Indications: Taltz is a humanized interleukin-17A antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Dosage/administration: For plaque psoriasis, Taltz is administered by subcutaneous injection. The recommended dose is 160 mg (2 80 mg injections) at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

Adverse reactions: Most common (≥1%) adverse reactions associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.

Citation:

Lilly’s Taltz receives first U.S. FDA approval for label update to include data for psoriasis involving genital area. [news release]. Indianapolis, IN: Eli Lilly and Company. May 22, 2018. http://www.pharmalive.com/lillys-taltz-receives-first-u-s-fda-approval-for-label-update-to-include-data-for-psoriasis-involving-genital-area/. Accessed May 29, 2018.