Approval in CSU for children 2 to 11 years of age is based on data from the LIBERTY-CUPID clinical trial program, including an extrapolation of efficacy data showing that Dupixent significantly reduced urticaria activity compared with placebo in adults

The latest approval expands Dupixent’s indication for CSU in the EU to children as young as 2 years; Dupixent is now approved for children less than 12 years of age across four chronic diseases driven in part by type 2 inflammation

 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the European Commission (EC) has approved Dupixent^® (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years with inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-immunoglobulin E (IgE) therapy for CSU. This expands the previous approvalin the EU for adults and adolescents aged 12 years and older with CSU, a chronic, inflammatory skin disease that causes sudden and debilitating hives and recurring itch.

“Young children suffering from chronic spontaneous urticaria often experience an unpredictable barrage of unrelenting itch and visible hives during the critical years of their growth and development. As the first and only targeted medicine for young children in the EU with CSU, Dupixent has the potential to become the new standard of care for those who remain symptomatic despite other available treatments,” 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 the most widely used innovative branded antibody medicine in the world, and this fourth approval for young children with chronic diseases driven in part by type 2 inflammation brings its proven efficacy and long-term safety profile to yet another vulnerable population in need.”

The approval in the EU is based on data from the LIBERTY-CUPID clinical trial program. This includes an extrapolation of efficacy data in adults from two Phase 3 trials (Study A and Study C) complemented by pharmacokinetic, safety and efficacy data from the single-arm CUPIDKids Phase 3 trial in children aged 2 to 11 years with CSU. Study A and Study C demonstrated Dupixent significantly reduced urticaria activity (a composite of itch and hives) and individual measures of itch and hive severity compared with placebo at week 24. Dupixent also increased the percentage of patients with well-controlled disease and complete response at week 24 compared with placebo.

Safety results from Study A, Study C and CUPIDKids were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. The most common adverse reactions for Dupixent overall are injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. Additional adverse reactions of injection site induration, injection site dermatitis and injection site bruising or hematoma were reported in the CSU adult and adolescent trials.* The adverse event more commonly observed with Dupixent (≥5%) than placebo in Study A and Study C in adults and adolescents with CSU was COVID-19. Safety data for children aged 2 to 11 years with CSU were generally consistent with the safety profile for adult and adolescent patients with CSU treated with Dupixent.

“Previous treatment options for young children with chronic spontaneous urticaria left many patients with uncontrolled disease where the unpredictable appearance of itch and hives continued to disrupt their daily lives,” said Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head, Immunology Development at Sanofi. “Dupixent, which inhibits signaling of IL-4 and IL-13, two of the key and central drivers of type 2 inflammation, provides a first-of-its-kind approach to addressing chronic spontaneous urticaria in young children. This approval demonstrates our commitment to extending the value of Dupixent to all who may benefit, including young children.”

In the U.S., the supplemental Biologics License Application (sBLA) for Dupixent has been accepted for review in certain children aged 2 to 11 years with CSU. Dupixent is currently approved for CSU in certain adults and adolescents in many jurisdictions, including the U.S. and Japan.

*Adverse reactions in adults and adolescents were pooled from Study A, Study B and Study C. Study B evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite H1AH use.