Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots:

• The EC has approved Dupixent to treat mod. to sev. CSU pts (≥12yrs.), who were symptomatic despite H1 antihistamine treatment & naïve to anti-IgE therapy based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program
• Study A & C (N=284) assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg received 200mg) vs PBO + antihistamines in CSU pts (≥6yrs.); Study B incl. 108 pts & provided additional safety data
• Both trials showed reduced urticaria activity, itch & hive severity at 24wks., & increased rates of well-controlled disease & CR

Ref: Regeneron | Image: Regeneron and Sanofi | Press Release

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