Dupilumab (Dupixent) is the first FDA-approved drug for CRSwNP in adolescents

The U.S. Food and Drug Administration (FDA) has expanded the approval of the anti-inflammatory type 2 biologic dupilumab (Dupixent) to patients ages 12 to 17 with chronic rhinosinusitis with nasal polyps (CRSwNP). The indication comes five years after the FDA originally approved Sanofi – Regeneron's interleukin-4 and -13 (IL-4; IL-13) inhibitor for adults ages 18 and older with CRSwNP.¹

Inadequately controlled forms of CRSwNP affect approximately 9,000 adolescents in the United States. The chronic upper respiratory disease is characterized by difficulty breathing, nasal congestion and discharge, and has adverse effects on quality of life, including sleep disturbances, impaired sense of smell and taste, and depression. The current standard treatment for patients is systemic steroids and surgery, although both options can still result in uncontrolled symptoms and recurrent complaints in this patient population.

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

The clinical profile in adolescents is based on pharmacokinetic data from patients 12 years of age and above with inadequately controlled CRSwNP and safety data from a clinical study evaluating dupilumab in adolescents 12 years of age and above with moderate to severe asthma.¹

The recent approval of dupilumab to treat a severe form of type 2 inflammatory disease in adolescents underscores Regeneron's “continued commitment to transforming treatment paradigms,” Dr. George D. Yancopoulos said in a statement.

“We are pleased to bring the proven efficacy and safety of Dupixent to the many children who suffer from chronic rhinosinusitis with nasal polyps that make their breathing more labored and difficult and can also rob them of their sense of smell,” said Yancopoulos, Regeneron's chairman, president and chief scientific officer. “More than one million patients worldwide are currently being treated with Dupixent, from infants to adults, and for a wide range of diseases exacerbated by type 2 inflammation, from asthma to atopic dermatitis.”

References

1. ^{Regeneron. Dupixent® (dupilumab) approved in the US as the first and only treatment for adolescents with chronic rhinosinusitis with nasal polyps (CRSwNP). Press release. Published online September 13, 2024. Retrieved 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 for the treatment of CRSwNP in patients 12 to 17 years of age. Contemporary pediatrics. Published on 13 May 2024. Retrieved 13 September 2024.}