French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) and US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) announced late Wednesday that the US Food and Drug Administration has approved Dupixent (dupilumab) for children aged two to 11 years with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment, extending its prior use in patients aged 12 years and older.

The decision is primarily supported by data from the LIBERTY-CUPID clinical programme, including Phase 3 studies demonstrating significant reductions in itch severity and urticaria activity versus placebo at 24 weeks.

Additional clinical evidence incorporated pharmacokinetic data from the CUPIDKids study in younger patients and safety data from multiple trials, including those involving patients unresponsive or intolerant to anti-IgE therapy. Across studies, Dupixent improved disease control outcomes in older populations, while paediatric safety findings were consistent with its established profile in dermatological indications.

The most common adverse event observed was injection site reactions, with no new safety signals identified in the paediatric population. The therapy is also approved for this indication in certain paediatric populations in the EU and other global markets.

Dupixent is now approved in more than 60 countries across multiple indications, with over 1.4 million patients treated worldwide. The biologic has been evaluated in more than 60 clinical studies involving over 12,000 patients and continues to be investigated in Phase 3 trials for additional conditions linked to type 2 inflammation.