Pune, India | November 25, 2025
Regeneron Pharmaceuticals and Sanofi have announced that the European Commission approved Dupixent® (dupilumab), delivering a landmark advancement. This decision introduces the first targeted therapy in more than ten years for moderate-to-severe chronic spontaneous urticaria (CSU) in patients twelve years and older. Consequently, this approval provides hope to around 270,000 adolescents and adults across Europe who continue suffering from persistent hives and severe itching despite standard antihistamine therapy.
The approval followed compelling Phase 3 clinical trial results showing that Dupixent significantly reduced both itch intensity and hives by week twenty-four. That is compared with a placebo. Importantly, the therapy targets two key inflammatory drivers, interleukin 4 (IL-4) and interleukin 13 (IL-13). It addresses the immune pathway responsible for CSU symptoms. By acting at the root of the disease, Dupixent offers a fundamentally different approach than conventional treatments.
“This approval marks a breakthrough for patients living with unpredictable and disabling hives,” stated George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. He added that Dupixent gives physicians a novel, first-line targeted option, offering patients new hope for meaningful symptom relief.
Tonya Winders, President and CEO of the Global Allergy & Airways Patient Platform, emphasized that patients often struggle with sudden flare-ups that severely affect daily life. She welcomed the approval, explaining that Dupixent has the potential to significantly improve the quality of life for those trying to manage this chronic condition.
This green light also expands Dupixent’s European indication to a seventh chronic inflammatory disease. It builds on prior approvals for other type 2 inflammation-driven conditions. Previously, Dupixent received EU approval for atopic dermatitis in children aged six to eleven. Therefore, this new approval reinforces its versatility and strengthens its role in treating multiple immune-mediated disorders.
Experts note that this extension could increase Dupixent’s significance in immunology due to its well-established safety profile. In pediatric studies, the most common adverse events included upper respiratory infections, injection site reactions, and conjunctivitis. Yet overall tolerability remained consistent. As a result, clinicians can confidently consider Dupixent for patients requiring targeted therapy.
Dupixent is delivered via subcutaneous injection and may be self-administered after appropriate training, according to EU labeling. Regeneron and Sanofi confirmed that eligible CSU patients can now access the therapy as a first-line targeted option. It is particularly for those who have had insufficient responses to standard antihistamines and are new to anti-IgE treatments. This approach ensures patients receive a therapy designed to address the underlying immune mechanism.
The drug was developed using Regeneron’s proprietary VelocImmune® technology, which allowed the creation of fully human monoclonal antibodies that block IL-4 and IL-13 signaling. This innovative approach enabled researchers to target disease pathways directly, validating Dupixent’s adaptability across multiple chronic inflammatory diseases. Consequently, the latest approval highlights the therapy’s growing clinical relevance.
CSU affects a significant patient population in Europe, many of whom have endured years with limited treatment options. Since the condition’s severity and duration can vary, having a targeted biologic available for first-line use represents a substantial shift in treatment. Physicians can now address disease biology rather than simply alleviating symptoms temporarily.
With this approval, healthcare providers in the EU gain a powerful tool for managing CSU. Patients who previously relied only on antihistamines may now benefit from a therapy that intervenes directly in the disease process. Furthermore, Regeneron and Sanofi plan to explore Dupixent’s potential in other type 2 inflammation-driven diseases, signaling continued innovation in targeted therapies.
In conclusion, the European Commission’s approval of Dupixent for chronic spontaneous urticaria represents a major scientific and therapeutic achievement. It addresses the unmet needs of thousands of patients, while solidifying Dupixent’s position as a leading targeted treatment in the broader landscape of inflammatory diseases. This decision demonstrates how precision medicine can transform patient care, offering hope and improved quality of life across Europe.
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