FDA approved Dupixent (dupilumab) on April 18, 2025, as the first new targeted therapy in over a decade for adults and adolescents aged 12+ with CSU symptomatic despite H1 antihistamines.1
Phase 3 trials showed Dupixent significantly reduced itch and hives versus placebo, with well-controlled disease in about 50% of patients.13
Oral remibrutinib, a BTK inhibitor, FDA-approved in September 2025, demonstrated rapid symptom improvement (1-2 weeks) in 65% of CSU patients.3
Over 300,000 US adults and adolescents have inadequately controlled CSU on antihistamines.1
EAACI 2025 Congress highlighted emerging therapies like barzolvolimab and briquilimab for better CSU control.4
Undiagnosed CSU rates are higher than previously thought in the US, with significant quality-of-life and work impacts.5
Sources:
1. https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-18-15-15-00-3064131
3. https://nextstepsinderm.com/derm-topics/chronic-spontaneous-urticaria-bringing-it-back-where-it-belongs-a-disease-state-update/
4. https://www.emjreviews.com/allergy-immunology/congress-review/updates-on-chronic-spontaneous-urticaria-eaaci-2025-j010125/
5. https://www.docwirenews.com/post/undiagnosed-csu-more-common-in-us-than-once-thought