Overview
- Sanofi and Regeneron said the FDA approved Dupixent for young children with uncontrolled chronic spontaneous urticaria, making it the first biologic available in the U.S. for this group.
- Chronic spontaneous urticaria is a pattern of itchy hives and sometimes swelling that appears almost daily for six weeks or more without a known trigger.
- Dupixent already had clearance for certain children aged two to 11 in the European Union and other countries, and the U.S. decision aligns the market with that earlier access.
- Sanofi reported first‑quarter revenue of €10.51 billion with Dupixent sales up 30.8% to €4.17 billion, highlighting strong demand across its approved uses.
- The companies operate the DUPIXENT MyWay program in the U.S. to help eligible patients who are prescribed the medicine get access and ongoing support.