ZACKS·2025-11-25 16:46Core Insights - The European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and above, who have an inadequate response to antihistamines and are naive to anti-IgE therapy [1][2][9] - Dupixent is the first targeted medicine approved for CSU in the EU in over a decade and is now approved for seven types of chronic inflammatory diseases in the EU [2][4] - Dupixent generated global product sales of €11.47 billion in the first nine months of 2025, reflecting a growth of 22.7% at a constant exchange rate, with expectations to reach around €22 billion in sales by 2030 [13] Company Performance - Sanofi's shares have gained 1.9% year to date, while the industry has seen a growth of 16% [3] - Regeneron recorded collaboration revenues of $4.24 billion from Sanofi during the first nine months of 2025, marking a year-over-year increase of 27.8% [13] Drug Approval and Studies - Dupixent was previously approved in the U.S. for CSU in April 2025, marking its seventh indication, and is also approved in Japan [4][5] - The approval in the EU is based on data from two late-stage studies (Study A and Study C) that demonstrated significant reductions in itch and hives compared to placebo at 24 weeks [9][10] - Safety data from the studies were consistent with Dupixent's known safety profile [11] Future Prospects - A supplemental biologics license application for Dupixent to treat allergic fungal rhinosinusitis (AFRS) is under priority review in the U.S., with a decision expected by February 28, 2026 [14]