Sanofi and Regeneron announced that the European Commission approved Dupixent (dupilumab) for the treatment of moderate‑to‑severe chronic spontaneous urticaria (CSU) in adults and adolescents 12 years and older. The approval, granted on November 25 2025, expands Dupixent’s EU indications beyond atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps.
The decision was based on two phase‑3 studies in the LIBERTY‑CUPID program, which showed that Dupixent, used as an add‑on to antihistamines, significantly reduced urticaria activity, itch, and hive severity. The drug’s mechanism—blocking IL‑4 and IL‑13—targets the key drivers of type‑2 inflammation that underlie CSU.
In the EU, roughly 270,000 adults and adolescents aged 12 and older suffer from CSU that remains symptomatic despite standard antihistamine therapy. The new indication therefore unlocks a sizable unmet‑need market and provides patients with a first targeted therapy after more than a decade of limited options.
Dupixent has already become a major revenue engine for Sanofi, with global sales of €11.47 billion in the first nine months of 2025, a 22.7% increase at constant exchange rates. Sanofi projects the drug to reach about €22 billion in sales by 2030. The CSU approval is expected to accelerate that trajectory by adding a new patient cohort and reinforcing the drug’s position as a cornerstone of Sanofi’s immunology portfolio.
"Dupixent is the only treatment that inhibits IL‑4 and IL‑13, two key drivers of type‑2 inflammation, and can offer patients significant improvement in debilitating itch and hives," said Dr. George Yancopoulos, Board co‑Chair and President of Regeneron. Sanofi’s Alyssa Johnsen, Global Therapeutic Area Head for Immunology, added, "The approval expands our portfolio and provides a new, evidence‑based option for patients who have not responded to antihistamines."
Sanofi’s strategic shift toward a pure‑play biopharma company places Dupixent at the center of its growth plan. The company’s focus on immunology, coupled with the drug’s strong safety profile and expanding indications, positions it to capture a larger share of the type‑2 inflammatory disease market and to deliver low‑double‑digit net sales growth through 2030.
The approval not only broadens Dupixent’s addressable market but also reinforces Sanofi’s leadership in type‑2 inflammatory diseases, supporting its broader strategy to become an immunology powerhouse and to drive long‑term revenue growth.
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