Dupixent® (dupilumab) Approved in the U.S. as the First Biologic Medicine for Young Children with Uncontrolled Chronic Spontaneous Urticaria (CSU)

Approval for children aged 2 to 11 years with CSU who remain symptomatic despite H1 antihistamine treatment based primarily on data from the LIBERTY-CUPID clinical trial program

CSU is a chronic skin disease that causes itch and hives that can be debilitating for young children, especially for those whose disease remains uncontrolled

CSU marks the fifth disease driven in part by type 2 inflammation for which Dupixent is approved in children younger than 12 years of age

TARRYTOWN, N.Y. and PARIS, April 22, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of children aged 2 to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment. This expands the previous approval for Dupixent in adults and adolescents aged 12 years and older with CSU.

“With this approval, Dupixent has become the first biologic medicine in the U.S. for young children suffering from uncontrolled chronic spontaneous urticaria, an unpredictable skin disease that impacts quality of life during these children’s most formative years,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. “Dupixent is now approved for nine different allergy-related conditions, from asthma to atopic dermatitis, and this is the fifth of these indications now extended to young children. The FDA’s authorization reinforces our medicine’s well-established safety profile and potential to transform outcomes for chronic diseases driven in part by type 2 inflammation impacting some of the most vulnerable populations. As the most widely used innovative branded antibody medicine, Dupixent has the potential to change yet another treatment paradigm.”

The approval is based primarily on data from the LIBERTY-CUPID clinical trial program. This includes extrapolation of efficacy and safety data from two Phase 3 trials (Study A and Study C) in certain adults and adolescents aged 12 years and older with CSU complemented with pharmacokinetics data from the single-arm, CUPIDKids Phase 3 trial in children aged 2 to 11 years with CSU. In Study A and Study C, Dupixent significantly reduced itch severity and urticaria activity (a composite of itch and hives) compared to placebo at week 24. In adults and adolescents, Dupixent also increased the likelihood of well-controlled disease or complete response compared to placebo at week 24. Study B provided additional safety data and evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use. Safety in children aged 2 to 11 years with CSU was supported by data from pediatric patients in other indications.

The safety results from all four CSU trials were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. In Study A, Study B and Study C, the most common adverse reaction (≥2%) in the U.S. Prescribing Information more frequently observed in patients on Dupixent compared to placebo was injection site reactions. No new adverse reactions were identified in children aged 2 to 11 years with CSU treated with Dupixent.

“Children with uncontrolled chronic spontaneous urticaria continue to experience the unpredictable appearance of debilitating itch and hives,” said Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head, Immunology Development at Sanofi. “Until now, these patients had to rely on limited treatment options that didn’t address potential critical mediators of chronic spontaneous urticaria. Dupixent is the first biologic approved for patients as young as 2 years of age, offering a targeted approach that inhibits IL-4 and IL-13 signaling, two key and central drivers of the type 2 inflammation that contributes to this disease. Today’s approval underscores our ongoing commitment to advancing therapies for young patients with significant unmet needs.”

In addition to the U.S., Dupixent is approved for CSU in certain children aged 2 to 11 years in the EU and other countries around the world.

About CSUCSU 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 more than 14,000 children in the U.S. aged 2 to 11 years living with CSU, 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 Trial ProgramThe LIBERTY-CUPID Phase 3 program evaluating Dupixent for CSU in children aged 2 to 11 years consists of CUPIDKids, Study A, Study B and Study C. CUPIDKids was a single arm clinical trial that assessed the safety, efficacy and pharmacokinetics of Dupixent in children aged 2 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 or four weeks or 300 mg every four weeks, 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 trials that assessed Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone in patients aged 6 years and older who remained symptomatic despite the use of antihistamines and were naïve to anti-IgE therapy. Study B was conducted in patients aged 12 years and older who were symptomatic despite use of antihistamines and were inadequate responders or intolerant to anti-IgE therapy. During the 24-week treatment period in all three trials, all patients received an initial loading dose followed by either 300 mg Dupixent every two weeks or, for pediatric patients weighing 30 kg to