FDA accepts Sanofi’s sBLA for Dupixent

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.

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