FDA Approves Dupilumab for Adolescents with Chronic Rhinosinusitis with Nasal Polyps

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent) as an add-on maintenance therapy for individuals aged 12 - 17 years with chronic rhinosinusitis with nasal polyposis (CRSwNP)._¹

The decision also expands the drug’s age range following the June 2019 approval for CRSwNP among those aged 18 years and older. The drug itself is a fully human monoclonal antibody which is designed to inhibit signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways among patients and is not an immunosuppressant.

“We are pleased to bring the well-established efficacy and safety of Dupixent to the many children suffering from chronic rhinosinusitis with nasal polyps…” George D. Yancopoulos, MD, PhD, Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal dupilumab inventor, said in a statement. “More than one million patients around the world are now being treated with Dupixent, from infants to adults, and across multiple diseases exacerbated by type 2 inflammation, from asthma to atopic dermatitis.”¹

CRSwNP is a recurring disease which is driven in part by type 2 inflammation obstructing patients’ sinuses and nasal passages, thereby impacting the upper airway. The condition is characterized by nasal discharge and congestion, breathing issues, issues related to sense of smell and taste, sleep issues, facial pressure, and overall quality of life decreases.²

When co-morbid conditions such as asthma exist alongside CRSwNP, they can result in high symptom burden, asthma attack increases, and significant adverse effects on patients’ health-related quality of life.

This FDA approval of dupilumab follows the 2019 approval for adults with CRSwNP, in addition to the recent announcement from Regeneron Pharmaceuticals and Sanofi that the FDA had accepted the drug’s supplemental Biologics License Application (sBLA) for Priority Review Designation.²

Support for the accepted sBLA resulted from positive phase 3 data resulting from 2 trials assessing adults with CRSwNP (SINUS-24 and SINUS-52). Additional recent findings indicated that 3 years of dupilumab treatment was effective for patients with CRSwNP, with long-term improvements observed for CRSwNP related to nasal polyp burden, symptoms, disease-related impairment, and olfactory function.^2,3

“Today’s approval reinforces our continuing commitment to transforming the treatment paradigms for these types of related diseases,” Yancopoulos concluded in his statement.¹

References

1. ^{Dupixent® (dupilumab) Approved in the U.S. as First and Only Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Regeneron. September 13, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-and-only-treatment. Date accessed: September 13, 2024.}
2. ^{Fitch J. FDA accepts sBLA for dupilumab to treat CRSwNP in patients aged 12 to 17 years. Contemporary Pediatrics. May 13, 2024. https://www.contemporarypediatrics.com/view/fda-accepts-sbla-dupilumab-treat-crswnp-patients-aged-12-to-17-years. Date accessed: September 13, 2024.}
3. ^{Smith T. Dupilumab Treatment Effective for Chronic Rhinosinusitis with Nasal Polyps. HCPLive. September 7, 2024. https://www.hcplive.com/view/dupilumab-treatment-effective-chronic-rhinosinusitis-nasal-polyps. Date accessed: September 13, 2024.}