FDA Expands Approval of DupixentJune 27, 2019
On June 26, 2019, the Food and Drug Administration (FDA) approved a supplemental biologics license application (BLA) for Dupixent (dupilumab; Sanofi and Regeneron Pharmaceuticals Inc.) as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). This is the first FDA-approved treatment for this indication.
FDA approval was supported by data from 2 placebo-controlled studies in patients with CRSwNP who were symptomatic despite taking intranasal corticosteroids. Patients who received Dupixent had statistically significant reductions in their nasal polyp size and nasal congestion compared with patients who received placebo.
Dupixent is a subcutaneously injected interleukin-4 receptor alpha antagonist that is administered via subcutaneous injection every other week. Dupixent was previously FDA-approved for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable; and as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma.
Food and Drug Administration (FDA). FDA approves first treatment for chronic rhinosinusitis with nasal polyps [news release]. June 26, 2019. Available at:
. Accessed June 26, 2019.