FDA OKs Update to Taltz Label for Genital Area Psoriasis

The US Food and Drug Administration (FDA) has approved an update to Eli Lilly and Company’s Taltz (ixekizumab) to include new data on psoriasis involving the genital area.

Taltz was first approved by the FDA for the treatment of adults with moderate to severe plaque psoriasis who are who are candidates for systemic therapy, phototherapy, or a combination of both. It is the only treatment currently approved by the FDA for moderate to severe plaque psoriasis that includes data on psoriasis in the genitals.

"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, MD, vice president, Lilly Immunology in a statement. "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."

Ixekizumab is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine, a naturally occurring protein that is involved in immune and inflammatory reactions. The binding inhibits IL-17A interaction with the IL-17 receptor.

The ixekizumab label update is based on data from a randomized, double-blind, placebo-controlled study in moderate to severe psoriasis involving the genital area.

"Psoriasis involving the genital area can significantly impact patients, yet it's not routinely examined by healthcare providers," said Caitriona Ryan, MD, lead study investigator. "The results from this clinical trial may raise awareness around the topic among healthcare providers."

The study included 149 patients with plaque psoriasis who were candidates for phototherapy or systemic therapy, and who failed to respond to or were intolerant of at least 1 topical therapy for the treatment of psoriasis affecting the genital area. Additionally, patients included had a minimum body surface area involvement of 1%, a static Physician Global Assessment (sPGA) score of ≥3 and a sPGA of genitalia score of ≥3.

The study reported a sPGA of genitalia score of 0 (clear) or 1 (minimal) for 73% of patients treated with ixekizumab compared to 8% of patients on placebo. Overall sPGA scores of 0 or 1 were 73% and 3% for the groups.

"The trial results found that the majority of patients treated with Taltz achieved clear or almost clear genital skin at week 12," said Jennifer Clay Cather, MD, Modern Research Associates, Dallas, Texas. "With these data, physicians can recommend Taltz as an effective treatment option for psoriasis in this area."

The label update for Taltz is effective immediately in the United States.

"This news is a significant step in providing patients with more options for treating their disease,” said Michael Siegel, PhD, senior vice president of research and clinical affairs, National Psoriasis Foundation. “We encourage patients to talk with their healthcare provider about their symptoms of psoriasis in the genital area."