Priority review for dupilumab to treat severe rhinosinusitisMay 8, 2019
Dupilumab (Dupixent) has been accepted for a priority review by US FDA as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP).
Patients with severe CRSwNP often experience recurrence despite previous treatment with surgery and/or systemic corticosteroids.
Currently, there are no FDA-approved biologic medicines to treat CRSwNP, a chronic disease of the upper airway predominantly driven by type 2 inflammation and characterized by polyps that obstruct the sinuses and nasal passages.
Regeneron and Sanofi presented data from two pivotal Phase 3 trials evaluating the efficacy and safety of dupilumab when combined with standard-of-care corticosteroid nasal spray in patients with recurring severe CRSwNP despite previous treatment with surgery and/or systemic corticosteroids.
Dupilumab is a human monoclonal antibody specifically designed to inhibit signalling of interleukin-4 and interleukin-13. The findings from these trials, as well as from prior trials in atopic dermatitis and asthma, demonstrate that both IL-4 and IL-13 are two key proteins that play a central role in type 2 inflammation, which seems to underlie CRSwNP as well as several other allergic diseases.
In the US, dupilumab is approved for treatment of adult patients with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin, or who cannot use topical therapies.