Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The target action date for the FDA decision is September 15, 2024. Dupixent is currently approved as an add-on maintenance treatment for adults with CRSwNP whose disease is not adequately controlled.

The sBLA in adolescents is supported by an extrapolation of efficacy data from two positive pivotal trials (SINUS-24 and SINUS-52) in adults with CRSwNP. These trials demonstrated that Dupixent significantly improved nasal congestion/obstruction severity, nasal polyp size and sense of smell, while also reducing the need for systemic corticosteroids or surgery, at 24 weeks compared to placebo. The sBLA was also supported by the safety data of Dupixent in its currently approved indications for adolescents.

Safety results in both SINUS-24 and SINUS-52 were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (=3%) compared to placebo in SINUS-24 and SINUS-52 (24-week safety pool) were injection site reactions and arthralgia. Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

The potential use of Dupixent in adolescents with CRSwNP has not been fully evaluated by any regulatory authority. CRSwNP is a chronic, recurring disease of the upper airway driven in part by type 2 inflammation that obstructs the sinuses and nasal passages. It can lead to breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, facial pressure, sleep disturbance, and overall reduction in quality of life. Many patients with CRSwNP have other type 2 inflammatory diseases, such as asthma that is often more severe and difficult to treat.

These co-morbid diseases can lead to an increased risk of asthma attacks, high symptom burden and a substantial adverse impact on health-related quality of life. In the pivotal adult Dupixent CRSwNP trials, 59% of patients also had asthma. Dupixent, which was invented using Regeneron?s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant.

The Dupixent development program 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. Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis (EoE), prurigo nodularis and chronic spontaneous urticaria (CSU) in different age populations. More than 850,000 patients are being treated with Dupixent globally.