FDA Sets Date For Resubmitted Dupixent in Inflammatory Skin Disease

The FDA has accepted the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU). The target action date for the FDA decision is April 18, 2025.

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 disese 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.

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. In September 2024, Dupixent received approved to treat patients with chronic obstructive pulmonary disease. It is the only biologic approved to treat COPD.

The list price of Dupixent is $3,803.20 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 resubmitted sBLA is supported by data from the multi-study LIBERTY-CUPID phase 3 clinical program (Study A, Study B, and Study C) for Dupixent in CSU.

The sBLA adds results from Study C, which was conducted in patients with uncontrolled chronic spontaneous urticaria who were on standard-of-care antihistamines. Study C met its primary and key secondary endpoints. Results showed Dupixent significantly reduced itch and urticaria activity (itch and hives).

Study C enrolled 151 children and adults; of these 74 patients received Dupixent added to antihistamines and 77 received placebo added to antihistamines. At 24 weeks, 41% of patients receiving Dupixent achieved well-controlled disease status and 30% had a complete response. Data were presented in October 2024 at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting in Boston.

Thomas B. Casale, M.D.

“Chronic spontaneous urticaria is an inflammatory skin condition that affects patients with unpredictable episodes of intense itching and hives, often severely impacting their daily lives. These data confirm results seen in the previous Study A and reinforce the potential of Dupixent to significantly alleviate symptoms for patients, helping them to better control this challenging disease,” Thomas B. Casale, M.D., professor, Internal Medicine, Morsani College of Medicine at the University of South Florida, said in a news release.

Safety results in all LIBERTY-CUPID phase 3 studies were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent compared with placebo were injection site reactions and COVID-19 infection.