Regeneron and Sanofi Report the US FDA’s Approval of Dupixent for Chronic Spontaneous Urticaria

Shots:

• The US FDA has approved Dupixent to treat CSU pts (≥12yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program; regulatory review ongoing in EU & other regions
• Study A & C assessed Dupixent (loading dose then 300mg Q2W; pts weighing <60kg received 200mg) as an add-on therapy vs PBO in 136 & 148 CSU pts (≥6yrs.), incl. biologic-naïve pts, meeting their 1EPs of reduced itch severity & urticaria activity at 24wks.
• Study B did not meet its 1EP but provided additional safety data on Dupixent in 108 pts (≥12yrs.) with inadequate response or intolerance to anti-IgE therapy who remained symptomatic despite antihistamine use; data from Study A & B was published in The JACI

Ref: Regeneron | Image: Regeneron & Sanofi

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