BRIEF—FDA label update for Lilly' Taltz

22 May 2018

Eli Lilly today announced that the US Food and Drug Administration has approved a label update for Taltz (ixekizumab) injection 80mg/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.1

"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 of 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," he added.

Taltz is approved to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz is also approved for the treatment of adults with active psoriatic arthritis.

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