First Drug OK’d for Chronic Rhinosinusitis With Nasal Polyps in Adolescents

The FDA broadened dupilumab’s (Dupixent) approval as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps to include adolescents as well, Regeneron Pharmaceuticals announced.

With the expended indication, the interleukin (IL-4) receptor alpha antagonist is approved for use in children ages 12 to 17 years with inadequately controlled disease, making it the only approved treatment for adolescents with the chronic condition. FDA originally approved the drug for chronic rhinosinusitis with nasal polyps in adults in 2019.

Data from the SINUS-24 and SINUS-52 trials — which formed the basis for the approval in adults — in part supported the new indication for adolescents. The phase III studies showed that adults with inadequately controlled disease assigned to dupilumab experienced improvements in nasal congestion/obstruction severity, nasal polyp size, and sense of smell compared with placebo recipients. The proportion of patients requiring systemic corticosteroids or surgery at 24 weeks was also reduced with dupilumab.

In addition, pharmacokinetic data comparing the IL-4 antibody in adolescents with asthma and adults with chronic rhinosinusitis with nasal polyps also supported the approval, as did safety data from an asthma trial involving children 12 years and older.

Roughly 9,000 adolescents in the U.S. have chronic rhinosinusitis with nasal polyps that remains inadequately controlled despite standard therapies.

The chronic upper airway disease can block sinuses and nasal passages and “lead to breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, facial pressure, sleep disturbance, and overall reduction in quality of life,” Regeneron stated in its press release. “Though systemic steroids and surgery are the standard treatment for [chronic rhinosinusitis with nasal polyps] in this age group and can provide relief, many patients may still experience uncontrolled symptoms and the recurrence of nasal polyps.”

According to the prescribing information, the following adverse events were more common in dupilumab-treated patients versus placebo recipients in SINUS-24 and SINUS-52: injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.

In chronic rhinosinusitis with nasal polyps, the biologic is given every other week as a 300-mg subcutaneous injection for adults and adolescents alike.

Beyond chronic rhinosinusitis, dupilumab is also approved for atopic dermatitis, asthma, eosinophilic esophagitis, and prurigo nodularis.

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