Sanofi’s supplemental Biologics License Application (sBLA) for Dupixent as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP) has been accepted for Priority Review in the US.
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 characterised by polyps that obstruct the sinuses and nasal passages.
The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent (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.
Data from these trials were presented at the Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in February 2019.
In addition to moderate-to-severe atopic dermatitis and moderate-to-severe asthma, this is the third type 2 allergic inflammatory disease in which Dupixent has demonstrated positive Phase 3 results.
The target action date for the FDA decision is June 26, 2019.