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The US Food and Drug Administration (FDA) has issued a complete response letter regarding the application for approval of dupilumab for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older, according to the manufacturers, pharmacy network operations at Regeneron and Sanofi.

The FDA letter “states that additional efficacy data are required to support an approval,” the press release says. No safety or manufacturing issues were cited, and an ongoing clinical trial “continues to enroll patients, with results expected in late 2024 that are anticipated to provide the additional efficacy data,” the statement adds.

Omalizumab (Xolair), an anti-IgE antibody, is the only biologic approved by the FDA for treating CSU in patients aged 12 years old and older.

Dupilumab (Dupixent), which inhibits the signaling of the interleukin (IL)-4 and IL-13 pathways, has been evaluated for CSU in two phase 3 trials in two populations, LIBERTY-CUPID A and B. (Study C is the ongoing study referred to in the company press release.)

Study A evaluated dupilumab as an add-on therapy to H1 antihistamines in comparison with antihistamines alone in 138 patients (aged 6 years and older) with CSU whose symptoms persisted and who had not been treated with omalizumab. Study B evaluated dupilumab in 108 patients (aged 12 to 80 years) with CSU who had symptoms despite standard-of-care treatment and who were intolerant of omalizumab or had experienced an incomplete response to it.

Medscape previously reported that in study A, among the patients treated with dupilumab, there was a 63% reduction in itch severity, compared with a 35% reduction in the group that received placebo, according to data presented at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) meeting.

In addition, among patients in the dupilumab group, there was a 65% reduction in the combined measure of severity of itch and hives, compared with a 37% reduction among those who received placebo. Adverse events were similar between groups; the most common were injection site reactions, according to the company.

In study B, which evaluated efficacy and safety, the company said results provided “additional supporting data” for the approval application.

In a poster presented at the European Academy of Dermatology and Venereology (EADV) Congress, which was held in October in Berlin, researchers found that patients with CSU who were treated with dupilumab experienced a significant drop in urticaria and an improvement in general and disease-specific health-related quality of life at week 24. Additionally, dupilumab was well tolerated, and safety was consistent with the known safety profile for dupilumab.

In addition to CSU, dupilumab is being studied for treatment of chronic inducible urticaria triggered by cold (LIBERTY-CINDU CUrIADS program) in an ongoing phase 3 trial and for treatment of a broad range of other diseases driven by type 2 inflammation.

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.

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