French drugmaker Sanofi SA (NASDAQ:SNY) and its partner Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) on Wednesday secured U.S. Food and Drug Administration (FDA) approval for Dupixent (dupilumab) for uncontrolled chronic spontaneous urticaria (CSU) in young children.
Sanofi, Regeneron Win FDA Approval
CSU is a skin condition characterized by itchy hives, swelling (angioedema), or both, appearing almost daily for six weeks or longer without an identifiable trigger.
The approval covers children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment, expanding the previous approval for Dupixent in adults and adolescents aged 12 years and older with CSU.
In February, the FDA approved Dupixent for treating allergic fungal rhinosinusitis in patients aged six years and older with …