FDA Reviews Dupixent sBLA for Chronic Spontaneous Urticaria Treatment

The U.S. Food and Drug Administration (FDA) has officially accepted for review a resubmitted supplemental biologics license application (sBLA) for Dupixent (dupilumab). This application aims to treat adults and children aged 12 years and older suffering from chronic spontaneous urticaria (CSU) whose condition is not adequately managed by H1 antihistamine treatments. The FDA's target date for a decision is April 18, 2025.

This latest resubmission is backed by data from the LIBERTY-CUPID phase 3 clinical program, which includes Study A, Study B, and Study C. Study C, in particular, focused on patients with uncontrolled CSU who were already receiving standard antihistamine treatments and confirmed the results seen in Study A. The findings showed significant reductions in itch and urticaria activity when using Dupixent compared to a placebo.

Regarding safety, the results from all phase 3 studies in the LIBERTY-CUPID program were generally consistent with the established safety profile of Dupixent in its approved uses. Common adverse events observed in at least 5% of patients included injection site reactions and COVID-19 infections.

Chronic spontaneous urticaria (CSU) is a long-term inflammatory skin condition marked by sudden hives and persistent itching. Often treated with H1 antihistamines that target certain cell receptors to control symptoms, CSU remains unmanaged in many patients despite this treatment, leaving them with limited options. The condition affects over 300,000 people in the U.S., significantly impairing their quality of life.

Dupixent’s evaluation in CSU through the LIBERTY-CUPID phase 3 study program consists of three studies: Study A and Study C in patients uncontrolled on standard antihistamines, and Study B in patients who were also refractory or intolerant to omalizumab. Dupixent has already received approval for CSU in Japan and the United Arab Emirates (UAE) and is under review in the European Union.

Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits IL4 and IL13 pathway signaling, without being an immunosuppressant. It has shown significant clinical benefits in reducing type-2 inflammation in various phase 3 studies. Dupixent is approved in over 60 countries for multiple indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, and chronic obstructive pulmonary disease, across different age groups. Globally, more than 1,000,000 patients are being treated with Dupixent.

The development of dupilumab is a collaboration between Sanofi and Regeneron, involving over 60 clinical studies with more than 10,000 patients across various chronic diseases driven by type-2 inflammation. Beyond its approved indications, dupilumab is being investigated for a range of other conditions, including chronic pruritus of unknown origin and bullous pemphigoid, although its safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

Regeneron, the biotechnology company behind Dupixent, focuses on inventing and developing medicines for serious diseases. Their proprietary technologies, such as VelociSuite®, enable the creation of human antibodies and bispecific antibodies. Regeneron is also advancing genetic medicine through its Regeneron Genetics Center®.

Sanofi, a global healthcare company, strives to improve lives through scientific advancements. They offer life-changing treatments and life-saving vaccines to millions worldwide, emphasizing sustainability and social responsibility in their goals.