Dupixent EU Recommendation, US Approval

Regeneron Pharmaceuticals and Sanofi announced significant regulatory advancements for their drug Dupixent. The European Union — European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending Dupixent's approval in the European Union for children aged 2 to 11 years with moderate-to-severe chronic spontaneous urticaria (CSU). Separately, the United States — Food and Drug Administration (FDA) approved Dupixent for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS). These approvals and recommendations are based on positive Phase 3 clinical trial data, demonstrating Dupixent's efficacy in reducing symptoms and treatment burden for these chronic inflammatory diseases. The drug is already approved for various indications in over 60 countries, and these new developments further solidify its market presence and potential for future growth.