FDA Approves Dupixent for Treatment of Chronic Spontaneous Urticaria

The U.S. Food and Drug Administration has granted approval for Dupixent (dupilumab) to be used in the treatment of adults and adolescents suffering from chronic spontaneous urticaria (CSU). This approval expands the use of Dupixent to include patients aged 12 years and older who continue to experience symptoms despite undergoing treatment with histamine-1 antihistamines.

The decision was supported by results from two phase 3 clinical trials that evaluated the efficacy and safety of Dupixent. These studies involved patients who had not previously received biologic therapy and showed persistent symptoms despite antihistamine treatment. Dupixent was administered as an add-on therapy alongside standard antihistamines and was found to significantly reduce itch severity and urticaria activity over a 24-week period.

In both trials, patients treated with Dupixent were more likely to achieve well-controlled disease or complete symptom relief compared to those receiving placebo. The safety profile observed aligned with what is already established for Dupixent in its other approved indications, indicating a generally well-tolerated treatment.

Alyssa Johnsen, M.D., Ph.D., the global head of immunology and oncology development at Sanofi, emphasized the impact of this approval, stating that uncontrolled CSU can cause profound discomfort and disrupt daily life. She highlighted that Dupixent offers a new therapeutic option targeting the underlying causes of this chronic condition.

This significant development offers hope for patients with challenging CSU symptoms, providing an effective new treatment approach to manage this burdensome skin disorder.

Source: https://medicalxpress.com/news/2025-04-fda-dupixent-chronic-spontaneous-urticaria.html