EU CHMP Recommends Sanofi's Dupixent for Pediatric CSU Ages 2-11
EMA's CHMP issued a positive opinion recommending EU approval of Sanofi/Regeneron's Dupixent for chronic spontaneous urticaria in children aged 2-11 years with inadequate response to H1 antihistamines, with a European Commission decision expected in two months. The pediatric approval intensifies competition in the CSU market and could affect Rhapsido uptake.
1. CHMP Positive Opinion
The EMA’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization for Dupixent to treat moderate-to-severe chronic spontaneous urticaria in children aged 2 to 11 who have an inadequate response to histamine-1 antihistamines. This opinion expands Dupixent’s label beyond adults and adolescents and is based on pediatric trial data demonstrating significant reductions in itch and hive severity.
2. Next Steps for EU Approval
The final decision by the European Commission is expected within the next two months. Upon approval, Sanofi and Regeneron plan to roll out Dupixent for the new pediatric indication across EU member states, leveraging existing manufacturing and distribution channels to support a rapid launch.
3. Market Impact and Competition
Chronic spontaneous urticaria affects about 40 million people worldwide, and this pediatric segment represents a meaningful growth opportunity for Dupixent in immunology. The expanded label will intensify competition with rival therapies, including Novartis’ oral BTK inhibitor Rhapsido, as companies vie for share in the CSU market.