Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)
Shots:
- FDA has approved Dupixent to treat CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, & P-III (CUPIDKids) trial
- Study A & C assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg received 200mg) vs PBO + antihistamines in CSU pts (≥6yrs.); CUPIDKids assessed Dupixent (200mg Q2W/Q4W or 300mg Q4W, with or without LD) in pts (2-11yrs.)
- In Studies A & C, Dupixent reduced itch severity & urticaria activity vs PBO at Wk. 24 & increased rates of well-controlled disease or CR, while Study B supported safety in pts
Ref: Regeneron | Image: Regeneron and Sanofi | Press Release
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