Regeneron Pharmaceuticals announced that the European Commission approved its drug Dupixent (dupilumab) for the treatment of moderate‑to‑severe chronic spontaneous urticaria (CSU) on November 25 2025. The approval marks the first targeted therapy for CSU in the European Union in more than a decade and expands Dupixent’s portfolio of IL‑4/IL‑13 inhibitors.
The decision was based on the LIBERTY‑CUPID phase 3 program, which included three pivotal studies (A, B, and C). Across the program, 1,200 patients received Dupixent as an add‑on to standard antihistamines, and the trials demonstrated a 70 % reduction in Urticaria Activity Score‑7 (UAS‑7) at 24 weeks versus 30 % for placebo. The data also showed a 60 % improvement in itch severity and a 55 % decrease in hives frequency, meeting the primary efficacy endpoint and supporting the regulatory submission.
The EU approval is expected to broaden Dupixent’s addressable market by an estimated 270,000 adults and adolescents who experience symptomatic CSU despite antihistamine therapy. In the United States, the drug generated $4.86 billion in global net sales in Q3 2025, a 27 % year‑over‑year increase, and contributed $1.62 billion in collaboration revenue from Sanofi. The new indication is projected to add a comparable volume of sales in the EU, reinforcing Regeneron’s leadership in type‑2 inflammatory diseases.
Regeneron’s President and Chief Scientific Officer, Dr. George Yancopoulos, said the approval “demonstrates the power of targeting IL‑4 and IL‑13 to control the underlying inflammation that drives CSU.” Sanofi’s Global Therapeutic Area Head, Dr. Alyssa Johnsen, added that the data “show Dupixent leads to well‑controlled disease or complete response in a higher proportion of patients than placebo.” These comments underscore the therapeutic advantage of Dupixent over existing options such as omalizumab, which remains the only approved biologic for CSU in the EU and has limited efficacy in many patients.
The approval also positions Regeneron to capture a growing segment of the chronic inflammatory disease market. With seven EU indications—including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease—Dupixent is a cornerstone of the company’s revenue engine. The new CSU indication is expected to accelerate sales growth, support the company’s 2025 guidance, and enhance the partnership with Sanofi, which continues to license Dupixent for EU markets.
The regulatory milestone is a key driver for Regeneron’s long‑term strategy to expand its biologic portfolio and deepen its presence in type‑2 inflammation. By adding CSU to its EU indications, Regeneron not only broadens its market reach but also strengthens its competitive positioning against other biologics such as omalizumab and newer IL‑4/IL‑13 inhibitors that are in development. The approval is likely to reinforce investor confidence in Regeneron's growth trajectory and its ability to translate clinical success into commercial performance.
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