The FDA has approved Dupixent for the treatment of chronic spontaneous urticaria (CSU) in adults and children aged 12 and older. CSU is a long-lasting, itchy skin condition that causes raised, red bumps, or welts (hives) to appear on the skin. The approval marks a significant milestone, as Dupixent becomes the first new targeted treatment for CSU in over a decade. This decision provides new hope for the estimated 300,000 people in the U.S. whose CSU symptoms are not well controlled by standard allergy medications.
CSU is an inflammatory condition that leads to unpredictable, recurring hives that can appear on any part of the body. These welts can last anywhere from 30 minutes to 24 hours. The cause of CSU remains unclear, but it is believed to be linked to allergic reactions and an immune response known as type 2 inflammation, a process also seen in conditions like asthma and eczema. While antihistamines are typically the first line of treatment, they do not work effectively for many people, highlighting the need for more specialized options.
Dupixent, developed by Sanofi and Regeneron, is a biologic drug that works by blocking certain pathways involved in type 2 inflammation, a key factor in CSU symptoms. It was first approved in 2017 for other conditions, including asthma and eczema. With this new approval, Dupixent becomes the seventh approved use for the drug. It is delivered via a prefilled pen for subcutaneous injection and is typically used alongside standard antihistamines. After the initial dose, Dupixent is administered every two weeks under the supervision of a doctor, either in a clinic or at home with proper training. For children aged 12 to 17, adult supervision is required for the injections.
The approval was based on the results of two studies involving 284 people aged 12 and older, who continued to experience symptoms despite using antihistamines. After 24 weeks of treatment, participants who received Dupixent as an add-on to antihistamines showed significant improvement in both itchiness and the frequency of hives compared to those who took antihistamines alone. Additionally, when compared to a placebo, Dupixent helped more people gain better control over their condition or achieve complete clearing of their symptoms after 24 weeks.
In terms of safety, Dupixent showed similar results to previous studies, with the most common side effect being a reaction at the injection site. Other side effects were generally mild, and the treatment was well-tolerated by most patients. This new approval for CSU provides patients with an effective option for managing this challenging condition, offering relief from the severe symptoms that can significantly impact daily life.
In addition to its use for CSU, Dupixent is already approved for several other conditions, including asthma, chronic sinus inflammation with nasal polyps, eosinophilic esophagitis, prurigo nodularis (itchy bumps on the skin), and chronic obstructive pulmonary disease (COPD). The approval of Dupixent for CSU is expected to improve the quality of life for many patients who previously struggled with limited treatment options.
With its demonstrated efficacy in clinical trials and its consistent safety profile, Dupixent offers a promising new tool for those affected by CSU. As the first new treatment in over ten years for this condition, it represents a significant advancement in dermatologic care, providing patients with greater hope for better symptom management and a higher quality of life.
