FDA OKs First Label Update to Include Data on Psoriasis Involving the Genital Area


Ixekizumab (Taltz, Eli Lilly) is the first and only treatment approved by the FDA for moderate-to-severe plaque psoriasis that includes data on psoriasis involving the genital area in its label.

The FDA has approved an updated label for Eli Lilly’s ixekizumab (Taltz) injection 80 mg/mL to include data in psoriasis involving the genital area, making it the first and only FDA-approved treatment for moderate-to-severe plaque psoriasis that includes such data in its label, according to a press release.

“Up to 63% of psoriasis patients will be impacted by psoriasis involving the genital area over the course of their disease,” Pete Salzmann, vice president, Lilly Immunology, said in the press release. “However, there remains a serious unmet need for patients seeking treatment options.”

Ixekizumab was approved by the FDA in March 2016 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In December 2017, the FDA approved the treatment for adults with active psoriatic arthritis.

The approved label update is based on data from a study in moderate-to-severe plaque 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 1 topical therapy, were treated with ixekizumab or a placebo.

At 12 weeks, patients treated with ixekizumab demonstrated significant improvement in the severity of psoriasis affecting the genital area, genital itch, and the patient-perceived impact of psoriasis involving the genital area on frequency of sexual activity, according to the data.

Ixekizumab should not be used in patients with previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or any of the excipients, according to the press release. Other warnings and precautions for ixekizumab include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease, and immunizations. Ixekizumab may also increase the risk of infection.

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


Lilly’s Taltz (ixekizumab) Receives the First US FDA Approval for Label Update to Include Data for Psoriasis Involving the Genital Area [news release]. Lilly’s website. http://lilly.mediaroom.com/index.php?s=9042&item=137776. Accessed May 23, 2018.

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