EU greenlights Dupixent for chronic urticaria, offering new hope to patients

It's a development that marks a major step forward for patients struggling with moderate-to-severe chronic spontaneous urticaria

The European Commission has approved Dupixent (dupilumab) for adults and adolescents aged 12 and older with moderate-to-severe CSU who have not responded adequately to standard antihistamine therapy and are new to anti-IgE treatments. The decision makes Dupixent a first-line targeted treatment option for eligible patients.

“The unpredictable nature of chronic spontaneous urticaria leaves patients guessing when they’ll have their next outbreak of disruptive, debilitating hives and itch, which can make life challenging,” said Tonya Winders, President & CEO, Global Allergy & Airways Patient Platform. “Dupixent is proven to reduce these intense symptoms and has the potential to make a positive impact on people struggling to control this disease.”

CSU, a condition marked by persistent hives and severe itching, often proves resistant to standard antihistamines. “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, Global Therapeutic Area Head, Immunology Development at Sanofi.

“Dupixent 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.”

The approval draws on results from two phase 3 clinical trials in the LIBERTY-CUPID program, which involved 284 patients aged 12 and older who remained symptomatic despite antihistamines and had not previously received anti-IgE therapy.

Dupixent, added to standard antihistamines, significantly reduced urticaria activity—including both itch and hives—after 24 weeks, while increasing the number of patients achieving well-controlled disease or complete response. An additional study of 108 patients provided further safety data for those intolerant or nonresponsive to anti-IgE therapy.

Safety findings were consistent with Dupixent’s known profile. Common side effects included injection site reactions, conjunctivitis, arthralgia, oral herpes, and eosinophilia.

Additional reactions observed in CSU studies included injection site induration, dermatitis, and hematoma. Events more frequent than placebo included injection site reaction, COVID-19, hypertension, CSU, and accidental overdose.

“The approval of Dupixent 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, Board co-Chair, President and Chief Scientific Officer at Regeneron.

“Physicians now have a new approach for CSU with Dupixent, as the only treatment that inhibits IL4 and IL13, 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 Dupixent to advance the treatment landscape for yet another chronic type 2 inflammatory disease, with a well-established safety profile across its indications.”

Dupixent is already approved for CSU in adults and adolescents in several countries.