Sanofi and Regeneron Expand Dupixent Approval in the EU to Include Young Children with Chronic Spontaneous Urticaria

(IN BRIEF) Sanofi and Regeneron have received European Commission approval for Dupixent to treat children aged two to 11 with chronic spontaneous urticaria, marking the first targeted therapy available for this condition in young patients. Supported by data from the LIBERTY-CUPID clinical program, the drug demonstrated significant improvements in reducing itching and hives while maintaining a safety profile consistent with previous uses. This approval expands Dupixent’s indications in the EU and highlights its growing role in treating diseases driven by type 2 inflammation, while regulatory review is also underway in the United States.

(PRESS RELEASE) PARIS, 13-Apr-2026 — /EuropaWire/ — Sanofi and Regeneron Pharmaceuticals have secured a new approval in the European Union for Dupixent, extending its use to treat children aged two to 11 years with moderate-to-severe chronic spontaneous urticaria (CSU). The decision by the European Commission introduces the first targeted therapy option for young children in this condition who have not responded adequately to standard antihistamine treatments and have not received anti-IgE therapy.

Chronic spontaneous urticaria is a persistent inflammatory skin disorder marked by unpredictable outbreaks of hives and intense itching, which can significantly disrupt daily life. Until now, treatment options for younger children have been limited, leaving many patients with ongoing symptoms during key developmental years.

Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head of Immunology Development at Sanofi, highlighted that Dupixent offers a novel mechanism by blocking the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), which are central drivers of type 2 inflammation. This targeted approach provides a new way to manage CSU in young children and reflects ongoing efforts to expand access to advanced therapies across broader patient populations.

The EU approval is supported by findings from the LIBERTY-CUPID clinical development program. This includes efficacy data extrapolated from two Phase 3 trials in adults, along with additional pharmacokinetic, safety, and efficacy data from the CUPIDKids Phase 3 study involving children aged two to 11 years. Across these studies, Dupixent demonstrated a meaningful reduction in urticaria activity—encompassing both itching and hives—compared to placebo at 24 weeks. The treatment also increased the proportion of patients achieving well-controlled disease or complete symptom resolution.

Safety outcomes observed in the trials were consistent with the established safety profile of Dupixent in dermatological uses. Commonly reported side effects include injection site reactions, conjunctivitis, joint pain, oral herpes, and elevated eosinophil levels. Additional injection site-related reactions were noted in studies involving adults and adolescents, while COVID-19 was reported more frequently among Dupixent-treated patients in certain study populations. In pediatric patients, safety findings aligned with those seen in older groups.

George D. Yancopoulos, MD, PhD, Board co-Chair, President, and Chief Scientific Officer at Regeneron, emphasized the potential of Dupixent to address a significant unmet need. He noted that children with CSU often endure persistent symptoms that affect both physical comfort and quality of life. As the first targeted therapy approved in the EU for this age group, Dupixent could redefine the standard of care for patients who remain symptomatic despite existing treatments.

This latest approval further broadens Dupixent’s role in treating diseases associated with type 2 inflammation, marking its fourth indication for use in young children within the EU. The therapy is already widely used globally and continues to expand into new indications and patient populations.

Beyond Europe, regulatory progress is ongoing. In the United States, a supplemental biologics license application for Dupixent in children aged two to 11 years with CSU has been accepted for review. The medication is already approved for use in certain adults and adolescents with CSU in multiple regions, including the US and Japan.

About CSU
CSU is a chronic, inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1AH, medicines that target H1 receptors on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite H1AH treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life.

About the Dupixent CSU phase 3 study program
The LIBERTY-CUPID phase 3 program evaluating Dupixent for CSU in children aged two to 11 years includes Study A, Study C, and CUPIDKids. CUPIDKids was a single arm clinical study that assessed the safety, efficacy, and pharmacokinetics of Dupixent in children aged two to 11 years with CSU who remained symptomatic despite the use of antihistamines. During the 24-week treatment period, Dupixent was administered at 200 mg every two (Q2W) or four weeks (Q4W) or 300 mg Q4W, with or without an initial loading dose, based on age and weight. The primary endpoint measured the serum concentration of Dupixent over time, including Ctrough (lowest concentration before the next dose) at Week 12 and Week 24.

Study A and Study C were replicate, double-blind, placebo-controlled clinical studies that assessed Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone in patients aged six years and older who remained symptomatic despite the use of antihistamines and were naïve to anti-IgE therapy. During the 24-week treatment period in both studies, all patients received an initial loading dose followed by either 300 mg Dupixent Q2W, or for pediatric patients weighing 30 kg to <60 kg, 200 mg Q2W.

In both studies, endpoints assessed at Week 24 included:

Change from baseline in itch and hives (weekly urticaria activity score [UAS7], 0-42 scale) the primary endpoint
Change from baseline in itch (measured by the weekly itch severity score, 0-21 scale), the key secondary endpoint
Change from baseline in hives (measured by the weekly hive severity score, 0-21 scale), secondary endpoint
Proportion of patients achieving well-controlled disease status (UAS7 ≤6)
Proportion of patients with complete response (UAS7=0)

About Dupixent
Dupixent (dupilumab) is an injection administered under the skin (subcutaneous injection) at different injection sites. In children aged two to 11 years with CSU who remain symptomatic despite H1AH treatment, Dupixent is administered based on age and weight. In children aged two to five years, Dupixent is administered at 200 mg Q4W for patients weighing ≥5 kg to <15 kg and 300 mg Q4W for ≥15 kg to <30 kg, without an initial loading dose. In children and adolescents aged six to 17 years, Dupixent is administered at 300 mg Q4W for ≥15 kg to <30 kg,** 200 mg Q2W for ≥30 kg to <60kg, and 300mg Q2W for ≥60 kg, after an initial loading dose. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home after training by a healthcare professional. In children aged two to 11 years, Dupixent should be administered by a caregiver if given at home.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, chronic obstructive pulmonary disease, bullous pemphigoid, and allergic fungal rhinosinusitis in different age populations. More than 1.4 million patients are being treated with Dupixent globally.

**For children and adolescents aged six to 17 years weighing 15 kg to <30 kg, the initial dose is 300 mg on Day 1 followed by 300 mg on Day 15. Subsequent doses are initiated four weeks after Day 15.

Dupilumab development program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 12,000 patients with various chronic diseases driven in part by type 2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

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Sanofi and Regeneron Expand Dupixent Approval in the EU to Include Young Children with Chronic Spontaneous Urticaria

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