The U.S. Food and Drug Administration (FDA) has granted approval to Dupixent (dupilumab) for use as an add-on maintenance treatment in adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This decision makes Dupixent the first biologic therapy specifically indicated for this age group, offering a new option for approximately 9,000 adolescents in the U.S. who continue to experience uncontrolled symptoms despite standard treatments. The approval was granted under Priority Review, a designation reserved for therapies that offer significant improvements in safety or efficacy.
Clinical Evidence Supporting Approval
The FDA's decision was supported by data from two pivotal trials, SINUS-24 and SINUS-52, conducted in adults with inadequately controlled CRSwNP. These trials demonstrated that Dupixent significantly improved several key indicators, including:
- Nasal congestion and obstruction severity
- Nasal polyp size
- Sense of smell
Furthermore, Dupixent reduced the need for systemic corticosteroids or surgery at 24 weeks compared to placebo. The efficacy data from these adult trials, along with pharmacokinetic data from adolescent patients with moderate-to-severe asthma and safety data from adolescents with asthma, supported the approval for the expanded indication.
Addressing Unmet Needs in CRSwNP
CRSwNP is a chronic inflammatory disease of the upper airway characterized by type 2 inflammation that obstructs the sinuses and nasal passages. This obstruction leads to a range of debilitating symptoms, including breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, facial pressure, and sleep disturbance. Current standard treatments, such as systemic steroids and surgery, often provide only temporary relief, with many patients experiencing recurrent nasal polyps and persistent symptoms.
George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, emphasized the significance of this approval, stating, "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 and Safety Profile
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, key drivers of type 2 inflammation. Unlike immunosuppressants, Dupixent specifically targets these inflammatory pathways without broadly suppressing the immune system. In the SINUS-24 and SINUS-52 trials, the safety profile of Dupixent was consistent with its known safety profile in other approved indications. Common adverse events included injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
Dosing and Administration
For both adults and adolescents with CRSwNP, Dupixent is administered via subcutaneous injection at a dose of 300 mg every other week.
Brian Foard, Executive Vice President, Head, Specialty Care at Sanofi, highlighted the importance of this new treatment option, noting, "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."
