The US Food and Drug Administration (FDA) has approved dupilumab for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 years and older who “remain symptomatic despite H1 antihistamine treatment,” according to a press release from the manufacturers, Regeneron Pharmaceuticals and Sanofi. 

Approval follows the FDA’s request in October 2023 for more efficacy data to support approval. In November 2024, the FDA accepted the resubmission of the application, which included additional data presented at the annual meeting of the American College of Allergy, Asthma, & Immunology that showed significant reduction in itching and hives with dupilumab compared with placebo in patients with CSU. 

Dupilumab (Dupixent) is already approved in the United States for several other indications including atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps, and prurigo nodularis. Dupilumab is a fully human monoclonal antibody that works by inhibiting the signaling of the IL-4 and IL-13 pathways, according to the company. 

The data supporting resubmission came from the third part of the LIBERTY-CUPID phase 3 program (LIBERTY-CUPID Study C) of children and adults patients with CSU. In that study, patients showed a significantly greater change from baseline to 24 weeks compared with placebo on the primary outcome measures of Itch Severity Score over 7 days and Urticaria Activity Score over 7 days.

Source: MEDspace