Shots:
- The EC has approved Dupixent to treat mod. to sev. CSU pts (age 2-11yrs.), 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, and CUPIDKids
- Study A & C assessed Dupixent (LD → 300mg Q2W or 200mg Q2W for 30–<60kg) as add-on vs antihistamines alone in CSU pts (≥6yrs., anti-IgE naïve), meeting 1EPs of reduced UAS7, itch & hive severity at 24wks., with higher rates of well-controlled disease & CR
- In the US, sBLA for Dupixent was accepted for review in children (2–11yrs.) with CSU; it is already approved for certain adults & adolescents in multiple markets, incl. the US & Japan
Ref: Sanofi | Image: Regeneron and Sanofi | Press Release
Related News: Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)
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