Pharma Focus Asia

Sanofi Announces U.S FDA Acceptance of Dupixent® (dupilumab) Application for Review

Wednesday, March 08, 2023

The U.S. Food and Drug Administration (FDA) has accepted, for review, the supplemental Biologics Licence Application (sBLA) for Dupixent® (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current standard of care, H1 antihistamine treatment.

The sBLA is supported by data from two Phase 3 trials (LIBERTY-CUPID Studies A and B), evaluating Dupixent in two different patient populations with uncontrolled CSU. Study A was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines with efficacy and safety data supporting the submission, while Study B was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines and refractory to omalizumab with results providing additional supporting data.

Dupixent is a fully human monoclonal antibody that inhibits the signalling of the IL-4 and IL-13 pathways and is not an immunosuppressant. The Dupixent development programme has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and eosinophilic oesophagitis (EoE).

Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 500,000 patients have been treated with Dupixent globally.

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