FDA Approves Dupilumab Label Expansion with Indication for CRSwNP in Adolescents

The FDA today approved the biologic dupilumab (Dupixent; Sanofi/Regeneron) as add-on maintenance therapy for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP), according to an announcement from Regeneron.

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The decision, following the agency's priority review of phase 3 clinical trial data, expands the original June 2019 indication in CRSwNP for individuals aged 18 years and older and makes the first such treatment available for adolescents with the chronic upper airway condition. Standard treatments for CRSwNP in the younger age group include systemic steroids and surgery. While both may provide relief, symptoms remain uncontrolled for as many as 9000 US adolescents who may also endure recurrence of nasal polyps. The chronic disease, driven in part by type 2 inflammation, obstructs sinuses and nasal passages, causing congestion, facial pressure, compromised sense of smell and taste, disrupted sleep, and reduction in quality of life.

“This latest approval for [dupilumab] 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,” Brian Foard, executive vice president and head, specialty care, at Sanofi, said in the press statement.

Dupilumab is a fully human monoclonal antibody that inhibits signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. IL-4 and IL-13 are key cytokines driving type 2 inflammation, which is implicated in multiple related and often comorbid inflammatory diseases. The injectable medication is not an immunosuppressant.

SINUS-24 and SINUS-25

The FDA's approval is based on review of efficacy data extrapolated from 2 pivotal phase 3 clinical trials in adults with uncontrolled CRSwNP, SINUS-24 and SINUS-52. Across the trials, dupilumab "significantly improved nasal congestion/obstruction severity, nasal polyp size and sense of smell, compared with placebo," according to Regeneron. The biologic also reduced the need for use of systemic corticosteroids or surgery at 24 weeks.

Providing additional support for the expanded label was pharmacokinetic data from adult and adolescent patients aged 12 years and older with moderate-to-severe asthma and adult patients with inadequately controlled CRSwNP, as well as safety data for use of dupilumab in adolescents aged 12 years and older with moderate-to-severe asthma. said the company.

The safety of dupilumab in SINUS-24 and SINUS-25 was consistent with the drug's known safety profile across its approved indications. Adverse events seen at a rate of 1% or more included injection site reaction, eosinophilia, gastritis, and arthralgia.

“We are pleased to bring the well-established efficacy and safety of [dupilumab] 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,” George D Yancopoulos, MD, PhD, board cochair, president and chief scientific officer at Regeneron, said in the statement. “Today’s approval reinforces our continuing commitment to transforming the treatment paradigms for these types of related diseases."

Source: Dupixent (dupilumab) approved in the US as first and only treatment for adolescents with chronic rhinosinusitis with nasal polyps (CRSwNP). News release. Regeneron. September 13, 2024. Accessed September 13, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-and-only-treatment