FDA approval of dupixent (dupilumab) to treat rhinosinusitis with nasal polyps

This approval expands the initial June 2019 FDA approval in CRSwNP for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.

CRSwNP is a chronic disease of the upper airway, driven in part by type 2 inflammation, that obstructs the sinuses and nasal passages. It can 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. Though systemic steroids and surgery are the standard treatment for CRSwNP in this age group and can provide relief, many patients may still experience uncontrolled symptoms and the recurrence of nasal polyps. In the U.S., approximately 9,000 adolescents live with inadequately controlled CRSwNP.

This latest approval for Dupixent 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,” said Brian Foard, Executive Vice President, Head, Specialty Care at Sanofi. “Dupixent is a cornerstone of our leadership in immunology, and this latest approval supports our continued commitment to chasing the miracles of science for patients with unmet medical needs.”

The approval is supported by evidence from two positive pivotal trials in adults with inadequately controlled CRSwNP. In the SINUS-24 and SINUS-52 trials.