FDA Considers New Dupilumab Data for CSU Indication

The US Food and Drug Administration (FDA) has accepted a resubmission of the supplemental Biologics License Application for dupilumab for the treatment of chronic spontaneous urticaria (CSU) in adults and youth aged ≥ 12 years for whom antihistamines are inadequate, according to an announcement from the manufacturer. 
The resubmission includes new data showing a significant reduction in itching and hives with dupilumab compared with placebo, according to a press release from Regeneron. The data were presented at the annual meeting of the American College of Allergy, Asthma & Immunology in October 2024.
Dupilumab, a fully human monoclonal antibody that inhibits the signaling of the interleukin (IL)-4 and IL-13 pathways, is currently approved in the United States for multiple indications including atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps, and prurigo nodularis.
The additional data, from the third part of the LIBERTY-CUPID phase 3 program (LIBERTY-CUPID Study C), showed a significantly greater change from baseline to 24 weeks than placebo on the primary outcome measures of Itch Severity Score over 7 days (ISS7) and Urticaria Activity Score over 7 days (UAS7).
Patients were randomized to placebo or subcutaneous dupilumab every 2 weeks as an add-on therapy at doses of 300 mg for adults and adolescents weighing ≥ 60 kg or 200 mg for adolescents weighing < 60 kg and children weighing ≥ 30 kg. 
Safety profiles across all three studies were consistent with dupilumab’s other indications, according to the company. The most common adverse events in patients on dupilumab compared with those on placebo were injection site reactions and COVID-19 infections.
The previous submission included data from LIBERTY-CUPID studies A and B, which involved, respectively, patients uncontrolled on standard antihistamines and those uncontrolled on antihistamines and refractory to or intolerant of omalizumab. These studies showed significant improvement in hives and itching with the addition of dupilumab to antihistamines from baseline compared with antihistamines alone. 
In October 2023, the FDA issued a complete response letter regarding the application, stating that more efficacy data were required to support approval. 
Dupilumab is also under review for CSU in the European Union and is approved for CSU in Japan and the United Arab Emirates.
 
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