FDA grants priority review to dupilumab for adolescents with CRSwNP

Key takeaways:

• Dupilumab’s supplemental biologics license application is for add-on maintenance treatment.
• Dupilumab would be the first treatment in the U.S. for chronic rhinosinusitis with nasal polyps in this age group.

The FDA has accepted for priority review the supplemental biologics license application of dupilumab for adolescents with chronic rhinosinusitis with nasal polyps, Regeneron Pharmaceuticals Inc. and Sanofi announced in a press release.

“Currently, there are no FDA-approved medicines for adolescents aged 12 to 17 years with CRSwNP, a condition that can lead to breathing difficulties, nasal congestion, and discharge, reduced or loss of sense of smell and taste, facial pressure and sleep disturbance,” a spokesperson for Sanofi and Regeneron told Healio. “If approved, this would provide a treatment option for this patient population.”

The FDA will review the supplemental biologics license application for dupilumab (Dupixent; Regeneron, Sanofi), a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling, as an add-on maintenance treatment for CRSwNP in adolescents aged 12 to 17 years. Dupilumab is currently only approved as an add-on treatment for adults whose CRSwNP is not adequately controlled.

The FDA application is supported by data from two positive trials in adults with CRSwNP, SINUS-24 and SINUS-52, that showed dupilumab significantly improved nasal congestion/obstruction severity, nasal polyp size and sense of smell compared with placebo at 24 weeks, while also reducing the need for systemic corticosteroids and surgery.

The application was also supported by current safety data for adolescents using the drug for other approved indications.

Compared with placebo, common adverse events included injection site reactions and arthralgia in SINUS-24 and SINUS-52.

The FDA set a target action date of Sept. 15.