The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This decision, announced by Regeneron and Sanofi on September 13, 2024, expands Dupixent's indication to include younger patients suffering from this chronic condition. The FDA granted Priority Review for this supplemental Biologics License Application, highlighting the potential for significant improvement in efficacy or safety for a serious condition.
CRSwNP is a chronic inflammatory disease affecting the upper airway, characterized by obstruction of the sinuses and nasal passages. This obstruction results in breathing difficulties, nasal congestion and discharge, reduced sense of smell and taste, facial pressure, and sleep disturbance, significantly impacting quality of life. In the United States, approximately 9,000 adolescents are affected by inadequately controlled CRSwNP.
Clinical Evidence and Efficacy
The approval is based on data from two pivotal trials, SINUS-24 and SINUS-52, conducted in adults with inadequately controlled CRSwNP. These trials demonstrated that Dupixent significantly improved nasal congestion/obstruction severity, reduced nasal polyp size, and enhanced the sense of smell compared to placebo at 24 weeks. Furthermore, Dupixent reduced the need for systemic corticosteroids or surgery. The safety profile of Dupixent in these trials was consistent with its known safety profile in other approved indications.
According to George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, "We are pleased to bring the well-established efficacy and safety of Dupixent to the many children suffering from chronic rhinosinusitis with nasal polyps, which can make their breathing more laborious and difficult, and also deprive them of their sense of smell."
Mechanism of Action
Dupixent is a fully human monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, which are key drivers of type 2 inflammation. By blocking these pathways, Dupixent helps to reduce inflammation and alleviate the symptoms of CRSwNP.
Current Treatment Landscape
While systemic steroids and surgery are often used to manage CRSwNP in adolescents, many patients continue to experience uncontrolled symptoms and recurrence of nasal polyps. Dupixent offers a new treatment option for these patients, addressing an unmet medical need.
Brian Foard, Executive Vice President, Head, Specialty Care at Sanofi, stated, "This latest approval for Dupixent marks the first time a biologic is specifically indicated for adolescents with chronic rhinosinusitis with nasal polyps, offering them an option beyond current standard of care."
