FDA Approves Dupixent for Inflammatory Skin Disease

The FDA has approved the resubmitted application of Dupixent (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU). It is indicated for patients who remain symptomatic despite histamine-1 (H1) antihistamine treatment.

Chronic spontaneous urticaria is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. This disease is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria. More than 300,000 people in the United States suffer from chronic spontaneous urticaria that is inadequately controlled by antihistamines.

“People with chronic spontaneous urticaria experience sudden, unpredictable hives and severe itch that cause a significant, and often overwhelming, burden on their everyday lives,” Kenneth Mendez, president and CEO at the Asthma and Allergy Foundation of America, said in a news release.

Developed by Regeneron and Sanofi, Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. It is approved for multiple indications, including atopic dermatitis, asthma, prurigo nodularis and eosinophilic esophagitis, as well as chronic obstructive pulmonary disease.

The list price of Dupixent is $3,993.36 per carton. For commercial patients, Sanofi offers a $0 copay card with an annual limit of $13,000. The company also offers patient assistance for those who qualify.

The FDA had issued a complete response letter in October 2023 for the chronic spontaneous urticaria indication and asked the companies to provide additional efficacy data to support an approval.

The approval is based on data from two phase 3 clinical trials, Study A (n=136) and Study C (n=148), which included biologic-naïve patients aged 12 years and older. The studies included patients (136 in Study A and 148 in Study C) who were symptomatic despite the use of antihistamines and assessed Dupixent as an add-on therapy to standard-of-care antihistamines, compared to antihistamines alone.

Both trials met their primary and key secondary endpoints with Dupixent demonstrating reductions in itch severity and urticaria activity (a composite of itch and hives) compared with placebo at 24 weeks. Dupixent also increased the likelihood of well-controlled disease or complete response compared with placebo at 24 weeks.

Study B, which included 108 patients, provided additional safety data and evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use.

Safety results from Study A, Study B and Study C were generally consistent with the known safety profile of Dupixent in its approved indications. In pooled data from all three trials, the most common adverse event seen in patients taking Dupixent was injection site reactions.