Healthcare company Eli Lilly and Company (NYSE:LLY) reported on Tuesday the receipt of the US Food and Drug Administration (FDA) label update approval for Taltz (ixekizumab) injection in 80 mg/ml to include data in psoriasis involving the genital area.
The company said Taltz is the first and only treatment approved by the US FDA for moderate-to-severe plaque psoriasis that includes psoriasis data in its label. Psoriasis is a chronic, immune disease that affects the skin and appears as raised, red patches covered with a silvery white buildup of dead skin cells.
Taltz (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses, added the company
This US approved label update is based on positive results from the company's first randomized, double-blind, placebo-controlled study in moderate-to-severe psoriasis involving the genital area. In the study, 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 one topical therapy for the treatment of psoriasis affecting the genital area, were treated with Taltz or placebo.
In conjunction with the study, Taltz demonstrated a significant improvement compared to placebo at 12 weeks in the severity of psoriasis affecting the genital area, as measured by static Physician Global Assessment (sPGA) score of genitalia score, according to the company.
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