Lilly’s psoriasis treatment first FDA approved to include data in psoriasis involving the genital area

Eli Lilly said Tuesday that the U.S. Food and Drug Administration (FDA) has approved a label update for Taltz injection 80 mg/mL to include data in psoriasis involving the genital area, making Taltz 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, while in December 2017, it was approved for the treatment of adults with active psoriatic arthritis.

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

Lilly said that Taltz demonstrated a significant improvement compared to placebo at 12 weeks in the severity of psoriasis affecting the genital area.

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