Dupilumab (Dupixent) becomes first FDA-approved drug for adolescent CRSwNP

The US Food and Drug Administration (FDA) expanded the approval of type 2 inflammation-targeting biologic dupilumab (Dupixent) to include patients aged 12 – 17 years old with chronic rhinosinusitis with nasal polyps (CRSwNP). The indication comes 5 years after the FDA originally approved the Sanofi – Regeneron interleukin 4 and 13 (IL-4; IL-13) inhibitor for adults aged ≥18 years old with CRSwNP.¹

Poorly controlled forms of CRSwNP affect approximately 9000 adolescents in the US. The chronic upper airway disease is characterized by difficult breathing, nasal congestion and discharge, and impacts on life quality including worsened sleep, sense of smell and taste, and depression. The current standard care for patients are systemic steroids and surgery, though both options may still result in uncontrolled symptoms and recurring conditions in this patient population.

Dupilumab’s latest indication was supported by data from the pivotal SINUS-24 and SINUS-52 clinical trials, wherein dupilumab significantly improved nasal congestion and obstruction severity versus placebo at 24 weeks. Patients also reported statistically significantly improved outcomes in the nasal polyp size, sense of smell, and need for standard-care systemic corticosteroids or surgery at 24 weeks.²

The adolescent clinical profile is informed by pharmacokinetic data from patients ≥12 years old with inadequately controlled CRSwNP, as well as safety data from a clinical trial assessing dupilumab in adolescents ≥12 years old with moderate to severe asthma.¹

The latest approval to treat a severe form of type 2 inflammatory disease in youths with dupilumab reinforces Regeneron’s “continuing commitment to transforming the treatment paradigms,” George D. Yancopoulos, MD, PhD, said in a statement.

“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,” Yancopoulos, board co-chair, president and chief scientific officer at Regeneron, said. “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.”

References

1. ^{Regeneron. Dupixent® (dupilumab) Approved in the U.S. as First and Only Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Press release. Published online September 13, 2024. Accessed September 13, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-and-only-treatment}
2. ^{Fitch J. FDA accepts sBLA for dupilumab to treat CRSwNP in patients aged 12 to 17 years. Contemporary Pediatrics. Published May 13, 2024. Accessed September13, 2024. https://www.contemporarypediatrics.com/view/fda-accepts-sbla-dupilumab-treat-crswnp-patients-aged-12-to-17-years}