Regeneron Dupixent Wins CHMP Nod for Children Aged 2–11 with CSU
The CHMP has issued a positive opinion recommending marketing authorization for Dupixent in children aged 2–11 with moderate-to-severe chronic spontaneous urticaria unresponsive to H1 antihistamines. European Commission approval is expected in two months, potentially expanding Regeneron’s share of Dupixent profits in the EU pediatric market.
1. CHMP Expansion for Pediatric CSU
The CHMP’s positive opinion recommends marketing authorization of Dupixent for children aged 2–11 with moderate-to-severe chronic spontaneous urticaria who have inadequate response to histamine-1 antihistamines and have not received anti-IgE therapy. A final European Commission decision is anticipated within two months, pending formal EU label update.
2. Commercial and Financial Impact
Under the Regeneron–Sanofi collaboration, Sanofi books global net sales of Dupixent while Regeneron records its share of profits; pediatric label expansion is expected to unlock a new revenue stream and reinforce Dupixent’s dermatology growth in the European Union.
3. Competitive Landscape
Novartis’ remibrutinib also secured CHMP backing for adult CSU, intensifying competition in the urticaria segment. Dupixent’s pediatric entry will test Regeneron’s ability to maintain market share against emerging oral BTK inhibitors and other biologics.