Dupixent Hits Another Milestone: EU Green Light for Chronic Skin Condition

Sanofi and Regeneron just got the European Commission’s thumbs up for Dupixent (dupilumab) to treat moderate-to-severe chronic spontaneous urticaria (CSU) in patients 12+. This is actually a big deal—it’s the first targeted drug approved for CSU in the EU in over a decade.

What’s CSU?

Basically, it’s a type II inflammatory skin condition that causes sudden, intense hives and swelling that antihistamines alone can’t control. Dupixent works as an add-on therapy for patients who don’t respond well to standard treatments.

The Numbers

Dupixent is now approved for 8 inflammatory diseases in the U.S. and 7 in the EU. Here’s the money part: in the first 9 months of 2025, Dupixent raked in €11.47 billion globally (up 22.7% YoY). Sanofi is projecting it’ll hit around €22 billion by 2030.

Regenerative’s cut? $4.24 billion in collaboration revenues from Sanofi in 9M 2025, up 27.8% YoY.

What’s Next?

The companies are currently seeking FDA approval for Dupixent to treat allergic fungal rhinosinusitis (AFRS)—that decision’s expected by Feb 28, 2026. If approved, it’d be Dupixent’s 9th U.S. indication.

Bottom line: Dupixent is basically printing money for both companies, and this EU nod just unlocked another revenue stream.