Regeneron, Sanofi Get Expanded Europe OK for Dupixent in Younger Children With CSU

The anti-inflammatory drug Dupixent now approved for children ages 2-11 with moderate-to-severe chronic spontaneous urticaria.

Apr. 13, 2026 at 10:34am

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An extreme close-up X-ray image revealing the intricate internal structures of a child's arm, conceptually representing the new treatment for chronic skin inflammation.The expanded approval of Dupixent for children with chronic spontaneous urticaria provides a new biologic treatment option to address this debilitating skin condition.Tarrytown Today

Regeneron Pharmaceuticals and Sanofi have received expanded regulatory approval from the European Commission for their blockbuster anti-inflammatory drug Dupixent to treat children ages 2 to 11 with moderate-to-severe chronic spontaneous urticaria (CSU). This follows the drug's previous approval for use in people 12 and older with CSU.

Why it matters

Chronic spontaneous urticaria is a debilitating skin condition that can significantly impact quality of life, especially in younger patients. This expanded approval for Dupixent provides a new treatment option for children struggling with this inflammatory disorder, potentially improving outcomes and easing the burden on families.

The details

Dupixent is a biologic drug that works by targeting specific proteins involved in the inflammatory response. The expanded approval covers the use of Dupixent in children ages 2 to 11 with moderate-to-severe CSU who have an inadequate response to antihistamines and have not previously received anti-immunoglobulin E therapy for CSU.

  • Regeneron and Sanofi won European approval of Dupixent for people 12 and older with CSU last year.
  • The latest expanded approval from the European Commission was announced on April 13, 2026.

The players

Regeneron Pharmaceuticals

A biotechnology company that created and co-markets Dupixent with Sanofi under a 2007 collaboration agreement.

Sanofi

A French pharmaceutical company that co-developed Dupixent with Regeneron and markets the drug internationally.

European Commission

The executive branch of the European Union that granted the expanded approval for Dupixent to treat children with chronic spontaneous urticaria.

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The takeaway

This expanded approval for Dupixent provides a new treatment option for children struggling with chronic spontaneous urticaria, a condition that can greatly impact their quality of life. The availability of this biologic drug for younger patients is an important step in addressing this inflammatory skin disorder and improving outcomes for affected families.