Recently, Dupilumab, a fully human monoclonal antibody has been approved by the U.S. Food and Drug Administration (FDA). It is currently approved for use in CSU (chronic spontaneous urticaria) in patients aged≥12 years. This groundbreaking ruling is a significant victory in the fight against Chronic Spontaneous Urticaria (CSU). This condition leads to persistent hives and severe pruritus, having a significant impact on patients’ quality of life.
This came as a surprise, since in October 2023, the FDA had asked Vaxart to provide more efficacy data. After that, they brought the first dupilumab, an inhibitor of IL-4 and IL-13 pathway signaling. These studies finalized that dupilumab represented a statistically significant improvement in itching and hives over placebo in patients with CSU. In November 2024, the FDA received dupilumab’s resubmission for chronic spontaneous urticaria (CSU). This decision emphasizes the drug’s capability to address important medical issues in this arena.
Dupilumab is administered subcutaneously every two weeks.
Dosage
For adults and adolescents 60 kg and above body weight, the recommended dosage is 300 mg. For adolescents weighing less than 60 kg, the recommended dose is 200 mg. Children weighing 30 kg or over need to take 200 mg. Dupilumab is approved as an add-on therapy to standard antihistamines. It increases their efficiency and delivers more effective relief.
Dupilumab was recently approved for CSU in the United States. Additionally, it has been approved for the same indication in Japan, the United Arab Emirates, and Brazil. This brings it within reach of nearly any corner of the world for those living with this debilitating disease. Dupilumab has been approved in the U.S. for 5 separate indications. These are atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps and prurigo nodularis.
Successful dupilumab’s story has been for other continents, the dupilumab saga through various regulatory approvals has not been without its hurdles. The application for CSU in the European Union was not reapplied for. Now, it has been re-resubmitted, strengthened this time by more data showing its positive impact.
Adam Friedman, MD, the chair of dermatology at George Washington University, praised this approval. He added, “CSU has really gone underappreciated in dermatology for too long, despite the fact that it truly fits under our umbrella.
Dupilumab continues to have a safety profile congruent with that of the dupilumab’s other approved indications. This level of consistency provides the utmost confidence for patients to undergo this groundbreaking treatment. The drug’s potency to improve chronic spontaneous urticaria emphasizes its relevance in dermatological treatment of patients and patient-oriented management strategies.
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