Regeneron Pharmaceuticals and Sanofi announced that the European Commission approved Dupixent (dupilumab) as a treatment for moderate-to-severe chronic spontaneous urticaria (CSU), a chronic inflammatory skin disease, on November 25th, 2025. The therapy is indicated for patients ages 12 and older with inadequate response to histamine-1 antihistamines and who are naïve to anti-immunoglobulin E therapy for CSU.
According to a company press release, dupilumab is a fully human monoclonal antibody designed to inhibit the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, which the company’s research has assessed as key drivers of the type 2 inflammation that in part characterizes diseases like CSU. The treatment is administered via a subcutaneous injection every two weeks after an initial loading dose. Prior to this approval, dupilumab had also been approved as a treatment for CSU in several other countries, including the United States and Japan.
Approval was based on data from two Phase III clinical trials in the LIBERTY-CUPID program. According to the release, Study A and Study C evaluated dupilumab as an add-on therapy to antihistamines compared to antihistamines alone, and demonstrated reduced urticaria activity and individual measures of itch and hive severity compared to placebo at 24 weeks.
“The approval of [dupilumab] for certain adults and adolescents with chronic spontaneous urticaria in the European Union represents the first innovation for patients with this disease in over a decade,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer, Regeneron, in the release. “Physicians now have a new approach for CSU with [dupilumab], as 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. This approval further demonstrates the ability of [dupilumab] to advance the treatment landscape for yet another chronic type 2 inflammatory disease, with a well-established safety profile across its indications.”
“Standard-of-care, first-line treatment options like antihistamines offer limited relief for many people living with uncontrolled chronic spontaneous urticaria, leaving them to face unrelenting cycles of itch and hives,” said Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head, Immunology Development, Sanofi, in the release. “[Dupilumab] significantly reduced these symptoms of CSU and led to more patients experiencing well-controlled disease or a complete response compared to placebo in two Phase 3 studies. Now, eligible patients with CSU in the EU have a new option that is proven to reduce itch and hives.”
