Regeneron Pharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of its drug Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in children aged two to eleven years. The recommendation covers children with moderate‑to‑severe CSU who have an inadequate response to antihistamine therapy and are naïve to anti‑IgE treatment, and is based on data from the LIBERTY‑CUPID clinical program, which includes two Phase 3 studies and a single‑arm CUPIDKids study.
The recommendation represents the first targeted medicine in the European Union for this pediatric population, expanding Dupixent’s addressable market and potentially adding a significant revenue stream. It also strengthens Regeneron’s position in the chronic urticaria segment, where Dupixent already holds a leading share in adult and adolescent patients. The approval could drive additional sales and reinforce the company’s strategy of leveraging its VelocImmune platform to broaden Dupixent’s therapeutic portfolio.
Regeneron’s Q4 2025 earnings provide context for the potential impact of the recommendation. The company reported total revenue of $3.884 billion, up 3% year‑over‑year, and Dupixent global net sales of $4.9 billion, up 34% year‑over‑year. These figures illustrate the strong commercial performance of Dupixent and the scale of the opportunity that the new pediatric indication could unlock.
CEO Leonard S. Schleifer highlighted the broader success of Dupixent, noting that the drug “received new approvals in Japan and Europe and is currently the most widely used innovative branded antibody medicine, with over 1.4 million active patients worldwide.” He also emphasized the role of Regeneron’s VelocImmune platform in enabling the development of fully human monoclonal antibodies such as Dupixent.
The CHMP recommendation is a positive opinion; a final regulatory decision is expected in the coming months. In parallel, the U.S. Food and Drug Administration is expected to review a supplemental biologics license application for the pediatric indication by April 2026, positioning Regeneron for a coordinated global approval strategy.
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