FDA approves Dupixent for chronic spontaneous urticaria, first targeted therapy in over a decade

Regeneron and Sanofi announced that the U.S. FDA has approved Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and older who continue to experience symptoms despite antihistamine treatment. This marks the first approval of a new targeted therapy for CSU in over ten years.

The approval is based on results from Phase 3 trials (Studies A and C) that demonstrated significant reductions in itch and hives compared to placebo. These studies also showed increased rates of well-controlled disease and complete response. Study B provided additional safety data in patients who previously had inadequate response or intolerance to anti-IgE therapy.

Key details:
- More than 300,000 people in the U.S. have CSU that remains uncontrolled with antihistamines.
- Dupixent becomes the seventh approved indication for conditions related to type 2 inflammation.
- Safety profile remains consistent, with the most common adverse event being injection site reactions.
- Dupixent is already approved for CSU in Japan, Brazil, and the UAE, with additional reviews underway in other regions.

Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling, important drivers of type 2 inflammation. It is not classified as an immunosuppressant. It is administered every two weeks via subcutaneous injection and is intended for use under medical guidance.

This new indication expands Dupixent’s use across multiple chronic conditions, including asthma, atopic dermatitis, eosinophilic esophagitis, and nasal polyps. The drug is currently used by over 1 million patients worldwide.