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Dupixent (Dupilumab) Under FDA Priority Review for Adolescent Chronic Rhinosinusitis with Nasal Polyposis Treatment

Monday, May 13, 2024

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi have shared a significant update regarding the potential treatment of adolescents grappling with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). They have submitted a supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to the U.S. Food and Drug Administration (FDA) for Priority Review. This application aims to expand Dupixent's approval as an add-on maintenance treatment for adolescents aged 12 to 17 years with CRSwNP.

Currently, Dupixent is approved for adults with CRSwNP whose condition remains inadequately controlled. The sBLA for adolescents is based on efficacy data extrapolated from two pivotal trials (SINUS-24 and SINUS-52) conducted in adults with CRSwNP. These trials demonstrated Dupixent's significant improvements in nasal congestion/obstruction severity, nasal polyp size, sense of smell, and reduced need for systemic corticosteroids or surgery at the 24-week mark compared to a placebo.

Safety data from Dupixent's current approved indications for adolescents supported the sBLA. The safety results from the pivotal trials were consistent with Dupixent's known safety profile, with injection site reactions and arthralgia being the most commonly observed adverse events.

Priority Review designation is granted to applications seeking approval for therapies that could provide significant advancements in treating serious conditions. It's worth noting that the potential use of Dupixent in adolescents with CRSwNP hasn't been fully assessed by any regulatory authority.

CRSwNP is a chronic condition of the upper airway driven, in part, by type 2 inflammation, causing sinus and nasal passage obstruction. It leads to various symptoms such as breathing difficulties, nasal congestion, reduced sense of smell, facial pressure, and sleep disturbances, significantly impacting the patients' quality of life. Many patients with CRSwNP also suffer from other type 2 inflammatory diseases, such as severe asthma, further complicating their treatment.

Dupixent, developed using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody inhibiting the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. It's not an immunosuppressant. Dupixent's development program has demonstrated significant clinical benefits by decreasing type 2 inflammation in Phase 3 trials, establishing IL-4 and IL-13 as key drivers of this inflammation across multiple related diseases.

Regeneron's VelocImmune technology utilizes a genetically engineered mouse platform with a humanized immune system to produce optimized fully human antibodies. This technology has been instrumental in creating several FDA-approved monoclonal antibodies, including Dupixent, REGEN-COV®, Libtayo®, and others.

Dupilumab, jointly developed by Regeneron and Sanofi, has been studied in over 60 clinical trials involving more than 10,000 patients with various chronic diseases driven by type 2 inflammation. Apart from the currently approved indications, ongoing Phase 3 trials are exploring its potential in treating other conditions, such as chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease, and bullous pemphigoid. However, the safety and efficacy of Dupilumab in these conditions are still under investigation and haven't been fully evaluated by regulatory authorities.



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