FDA Approves Sanofi/Regeneron’s DUPIXENT as First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria
Regeneron Pharmaceuticals and Sanofi have announced that the FDA has approved DUPIXENT (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with histamine-1 (H1) antihistamines. This approval marks the first new targeted therapy for CSU in over a decade. The decision is based on the results of two Phase III trials, which showed that DUPIXENT significantly reduced itch severity and urticaria activity when used in combination with antihista...
