Pune, India | November 25, 2025
Regeneron Pharmaceuticals and Sanofi recently announced that the European Commission approved Dupixent® (dupilumab), marking a significant milestone. This approval introduces the first targeted therapy in over ten years for treating moderate-to-severe chronic spontaneous urticaria (CSU) in patients aged twelve years and older. Consequently, this decision provides new hope for roughly 270,000 adolescents and adults across the European Union who continue suffering from persistent hives and itching despite standard antihistamine treatment.
Regulatory approval followed compelling evidence from Phase 3 clinical trials, which demonstrated that Dupixent significantly reduced both itch intensity and hives by week twenty-four compared with placebo. Importantly, the therapy specifically targets two key inflammatory molecules, interleukin 4 (IL-4) and interleukin 13 (IL-13). Thereby addressing the underlying immune pathways responsible for CSU symptoms. By intervening at the disease’s root, the medicine offers a fundamentally different approach than traditional therapies.
“This approval represents a long-awaited breakthrough for patients experiencing unpredictable and disabling hives,” stated George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. He further emphasized that Dupixent provides physicians with a novel, first-line targeted treatment option for CSU. It offers patients hope for sustained symptom relief.
Tonya Winders, President and CEO of the Global Allergy & Airways Patient Platform. It highlighted that patients frequently endure sudden flare-ups that severely disrupt daily life. She welcomed the European Commission’s approval, explaining that Dupixent could make a tangible difference for individuals struggling to manage this chronic illness effectively.
This approval also expands Dupixent’s indication to a seventh chronic inflammatory disease in Europe. It is building on its prior approvals for other type 2 inflammatory conditions. Previously, Dupixent had received EU authorization for treating atopic dermatitis in children aged six to eleven years. Therefore, the new indication strengthens its role as a versatile therapy across multiple immune-mediated diseases.
Industry analysts suggest that this expansion could reinforce Dupixent’s importance in immunology care due to its well-established safety profile. In pediatric studies, the most commonly reported adverse events included upper respiratory infections, injection site reactions, and conjunctivitis. Yet overall tolerability remained consistent. As a result, physicians can confidently consider this treatment for eligible patients, knowing its safety and efficacy have been well-documented.
Dupixent is administered via subcutaneous injection and can be self-administered following appropriate training, according to its EU-approved labeling. Regeneron and Sanofi confirmed that eligible CSU patients may now receive Dupixent as a first-line targeted therapy. It is particularly for those who have had insufficient responses to standard antihistamines and who have not previously used anti-IgE therapies. This approach ensures that patients receive a treatment designed specifically for their condition’s underlying biological drivers.
The drug was developed using Regeneron’s proprietary VelocImmune® technology. It enabled the creation of fully human monoclonal antibodies that block IL-4 and IL-13 signaling. This innovative platform allowed researchers to design a therapy capable of effectively addressing the immune mechanisms underlying type 2 inflammatory conditions. Consequently, the latest approval validates Dupixent’s adaptability across multiple chronic, inflammation-driven diseases, demonstrating its growing therapeutic impact.
Chronic spontaneous urticaria affects a considerable portion of the European population, many of whom have endured years of limited treatment options. Since the condition can vary widely in severity and duration. The availability of a targeted biologic therapy for first-line use represents a major shift in clinical care. Physicians can now offer patients a treatment that intervenes directly in the disease process rather than merely alleviating symptoms temporarily.
This approval equips healthcare providers in the EU with a highly effective tool for managing CSU. Patients who previously relied exclusively on antihistamines may now access a therapy capable of addressing the disease at its immunological core. Additionally, Regeneron and Sanofi have expressed an ongoing commitment to exploring Dupixent’s potential in other diseases where type 2 inflammation plays a critical role, signaling continued innovation in targeted therapeutics.
In conclusion, the European Commission’s approval of Dupixent for chronic spontaneous urticaria represents both a scientific and clinical milestone. It addresses the unmet needs of thousands of patients who have long struggled with limited options, while reinforcing Dupixent’s position as a leading targeted therapy in the treatment of inflammatory diseases. This decision exemplifies how precision medicine can transform patient care and improve quality of life across the EU.
