FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease

On Friday, the FDA accepted for review the resubmission of the supplemental biologics license application (sBLA) for Regeneron Pharmaceuticals' Dupixent (dupilumab) for patients ages 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment.