Sanofi SA and Regeneron have received approval from the European Commission for Dupixent (dupilumab) as the first targeted medicine in over a decade for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who have an inadequate response to histamine-1 antihistamines and are naïve to anti-IgE therapy. The approval is based on positive results from two phase 3 clinical studies, demonstrating that Dupixent significantly reduced itch and hives compared to placebo. Dupixent is now approved for CSU patients across the EU and is also authorized for this indication in several other countries, including the US and Japan. This regulatory approval was obtained jointly by Sanofi SA and Regeneron.