, 2025-04-18 17:06:00
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.
Patients were randomized to placebo or one of two treatment groups: subcutaneous dupilumab every 2 weeks as an add-on therapy at doses of 300 mg for adults and adolescents weighing 60 kg or more; or 200 mg for adolescents weighing less than 60 kg and children weighing 30 kg or more.
The most common adverse events in dupilumab-treated patients were injection site reactions, according to the press release announcing approval.
The original submission of dupilumab for treatment of CSU included data from LIBERTY-CUPID studies A and B. These studies enrolled patients uncontrolled on standard antihistamines (study A) and those uncontrolled on antihistamines and refractory to or intolerant of omalizumab (study B). In these studies, patients showed significant improvement in disease activity from baseline with the addition of dupilumab to antihistamines compared to antihistamines alone. Safety profiles were consistent with dupilumab’s other indications across all three studies.
“CSU has really gone unseen in dermatology for too long, even though it belongs under our umbrella,” said Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, DC. “Now, with an additional FDA-approved option, one with which we all should have familiarity and comfort for other indications, it’s an opportunity to welcome this large patient population -1% in the US-into our practices,” he told Medscape.
Dupilumab is approved for CSU in Japan, the United Arab Emirates, and Brazil. It had been under review for CSU in the European Union, but the application was withdrawn so the company can resubmit an updated application with additional data, according to the European Medicines Agency.
Friedman is a speaker and consultant for Regeneron.