The FDA has approved Dupixent as the first new targeted therapy in over ten years for chronic spontaneous urticaria in patients aged 12 and older who remain symptomatic despite antihistamine treatment.
The approval is based on data from three phase 3 trial results which showed that Dupixent, when added to standard antihistamine treatment, reduced itch severity and hives more than antihistamines alone after 24 weeks, according to an April 18 Sanofi press release.
CSU is a chronic skin condition that causes unpredictable hives and itching. In the U.S., more than 300,000 individuals aged 12 and older live with CSU and do not respond to antihistamines. The condition is linked to Type 2 inflammation, which Dupixent helps target by blocking certain immune signaling pathways.
The injection is already approved for CSU in several other countries, including Japan and Brazil, and regulatory reviews for other countries are ongoing.
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