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Dupilumab has received FDA approval for chronic spontaneous urticaria in patients aged 12 years and older, expanding its use to over 300,000 U.S. patients following new efficacy data.
In a major step forward for dermatology care on 18 April 2025, the Food and Drug Administration (FDA) has authorized dupilumab for treating patients aged 12 years and older with chronic spontaneous urticaria (CSU)—a challenging skin disorder marked by recurring itchy hives and deep tissue swelling (angioedema) with no known trigger. This condition can severely impact the patient’s quality of life, making this approval a significant milestone for those seeking relief.
This decision follows an earlier regulatory setback in 2023, when the FDA requested more comprehensive data on the drug's efficacy in CSU. The recent approval indicates that the submitted data has sufficiently demonstrated the drug’s benefits for this patient group. Dupilumab, an injectable biologic that targets interleukin-4 and interleukin-13 pathways, plays a critical role in modulating type 2 inflammation—a key driver in various allergic and atopic conditions.
With this approval, dupilumab becomes a new treatment option for patients with CSU who may not respond adequately to antihistamines and other standard therapies. Dupilumab has already proven effective in managing several immune-mediated diseases, including asthma, eczema and a chronic lung condition in the U.S. In 2025, the drug continues to reinforce its position as a leading therapy in the immunology space.
Reuters
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