Tarrytown, New York, USA & Paris, France – April 22, 2026

In a significant advancement for pediatric immunology and dermatology, Regeneron Pharmaceuticals and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for children aged 2 to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite standard antihistamine therapy. This milestone marks the first biologic therapy approved in the U.S. for young children with uncontrolled CSU, addressing a critical unmet need in pediatric patients suffering from this debilitating condition.

First-in-Class Biologic Expands Pediatric Treatment Options

The FDA approval establishes Dupixent as a groundbreaking targeted biologic therapy for children living with CSU, a chronic inflammatory skin disease characterized by severe itching and recurrent hives that significantly impact quality of life. Until now, treatment options for pediatric CSU patients were limited primarily to antihistamines, leaving many children inadequately controlled.

Dupixent works by inhibiting interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, which are key drivers of type 2 inflammation, the underlying mechanism in CSU and several other allergic diseases. By targeting these pathways, the therapy provides a disease-modifying approach rather than just symptomatic relief, positioning it as a transformational advancement in pediatric immunology care.

This approval further expands Dupixent’s growing portfolio, making it approved across multiple type 2 inflammatory diseases, and reinforces its role as a leading monoclonal antibody therapy globally.

Advertisement

cGxPJobs Banner

Robust Phase 3 Data Demonstrates Clinical Efficacy

The approval is supported by data from the LIBERTY-CUPID Phase 3 clinical trial program, which demonstrated that Dupixent achieved statistically significant reductions in itch severity and urticaria activity scores compared to placebo at 24 weeks. These outcomes are critical indicators of disease control and patient well-being.

Patients treated with Dupixent also showed an increased likelihood of achieving well-controlled disease or complete response, reinforcing its clinical effectiveness across multiple endpoints. Importantly, the safety profile remained consistent with previous studies, with injection site reactions being the most commonly observed adverse event, and no new safety concerns identified in the pediatric population.

These findings validate Dupixent’s ability to deliver meaningful clinical benefits while maintaining a favorable safety profile, supporting its use in younger patients with limited treatment alternatives.

Transforming Pediatric Care in Chronic Inflammatory Diseases

The approval of Dupixent for pediatric CSU represents a major advancement in the treatment landscape, offering clinicians a targeted biologic therapy that addresses the underlying drivers of disease rather than just symptoms. This is particularly important for children, where early and effective intervention can prevent long-term complications and improve overall quality of life.

Dupixent has already demonstrated global clinical impact, with approvals in more than 60 countries and use in over 1.4 million patients across multiple indications. Its continued expansion into new therapeutic areas reflects the growing importance of precision medicine and biologic therapies in modern healthcare.

Administered via subcutaneous injection with dosing tailored to patient weight and age, Dupixent offers flexibility for both clinical and at-home use under medical supervision, making it accessible for pediatric patients and caregivers.

As research into type 2 inflammatory diseases continues to advance, Dupixent is positioned to play a central role in redefining treatment standards, delivering innovative, targeted solutions that improve outcomes for patients with chronic immune-mediated conditions.

Source: Regeneron, Sanofi press release