Wedoany.com Report-Nov. 29, The European Commission has approved Dupixent (dupilumab), developed by Sanofi and Regeneron, as the first targeted biologic therapy for adults and adolescents aged 12 years and older with moderate-to-severe chronic spontaneous urticaria (CSU) whose disease remains uncontrolled despite H1 antihistamine treatment and who have not previously received anti-IgE therapy. This positions Dupixent as a first-line advanced treatment option for eligible patients across the European Union.

The decision follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued two months earlier.

"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."

Dr Alyssa Johnsen, Global Therapeutic Area Head, Immunology Development at Sanofi, added: "Standard-of-care, first-line treatment options such as antihistamines offer limited relief for many people living with uncontrolled chronic spontaneous urticaria, leaving them to face unrelenting cycles of itch and hives. Now, eligible patients with CSU in the EU have a new option that is proven to reduce itch and hives."

Approval is supported by the Phase III LIBERTY-CUPID programme. Study A and Study C enrolled 284 antihistamine-refractory patients aged 12 and older who were anti-IgE therapy naïve. When added to standard antihistamines, Dupixent significantly reduced weekly urticaria activity scores (itch and hive composite) as well as individual itch and hive severity at 24 weeks compared with antihistamines alone. It also markedly increased the proportion of patients achieving well-controlled disease and complete response.

Study B evaluated Dupixent in 108 patients intolerant or inadequately responsive to prior anti-IgE therapy, providing confirmatory safety data. The overall safety profile remained consistent with Dupixent's established record across its approved indications.

Dr George D. Yancopoulos, Board co-chair, President and Chief Scientific Officer at Regeneron, stated: “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 more than a decade. 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 now authorised for this CSU indication in multiple markets worldwide, including the United States and Japan, offering a new therapeutic choice for patients who previously had limited options beyond antihistamines and anti-IgE treatments.