FDA Expands Dupixent Label to Include Adolescent Patients with Chronic Rhinosinusitis with Nasal Polyps
Key Insights
The FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps (search) (CRSwNP) in adolescent patients aged 12-17 years.
This expands the initial FDA approval from June 2019, which was limited to CRSwNP patients aged 18 years and older, addressing a significant unmet need in younger patients.
The approval is based on data from the SINUS-24 and SINUS-52 trials, demonstrating significant improvements in nasal congestion, polyp size, and sense of smell compared to placebo.
Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY) have received FDA approval to expand the label for Dupixent (dupilumab) to include adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (search) (CRSwNP). This decision marks a significant step forward in treating this chronic condition in a younger population, addressing a critical unmet need.
The FDA's approval was based on data from two pivotal trials, SINUS-24 and SINUS-52, which evaluated Dupixent in adult patients with inadequately controlled 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 approval also incorporates pharmacokinetic data from adult and adolescent patients aged 12 years and older with moderate-to-severe asthma, along with safety data for Dupixent in adolescents aged 12 years and older with moderate-to-severe asthma.
CRSwNP is a chronic upper airway disease driven by type 2 inflammation, obstructing the sinuses and nasal passages. Approximately 9,000 adolescents in the United States are affected by this condition. The expanded approval offers a new treatment option for these young patients who have had limited therapeutic solutions.
Dupixent, a monoclonal antibody, targets the IL-4 and IL-13 pathways, key drivers of type 2 inflammation. It is administered as an add-on maintenance therapy. The initial FDA approval for Dupixent in CRSwNP was granted in June 2019 for patients aged 18 years and older.
Regeneron and Sanofi are also evaluating dupilumab in late-stage studies for chronic spontaneous urticaria (search) (CSU), chronic pruritus of unknown origin, chronic obstructive pulmonary disease (search) with evidence of type 2 inflammation, and bullous pemphigoid (search). The companies plan to resubmit a regulatory filing before year-end seeking label expansion for Dupixent in CSU indication, following encouraging data from the confirmatory phase III LIBERTY-CUPID C study.
Dupixent's strong performance has been crucial for Regeneron, helping to offset declining sales of Eylea, which faces increasing competition from Roche's Vabysmo. Vabysmo, designed to block pathways involving Ang-2 (search) and VEGF-A (search), generated CHF 1.8 billion in the first half of 2024, driven by strong demand across all regions.