Regeneron, Sanofi announce FDA Priority Review of sBLA for Dupixent

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for Priority Review the supplemental Biologics License Application, or sBLA, for Dupixent as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps, or CRSwNP. Patients with severe CRSwNP often experience recurrence despite previous treatment with surgery and/or systemic corticosteroids. The target action date for the FDA decision is June 26, 2019. 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. Patients may experience severe nasal obstruction with breathing difficulties, nasal discharge, reduction or loss of sense of smell and taste, and facial pain or pressure. Persistent symptoms of CRSwNP have a substantial adverse impact on patients’ health-related quality of life, which can be measured by a composite that includes reduced productivity and activities of daily living, inability to enjoy food, lack of sleep and fatigue. People with co-morbid asthma and CRSwNP tend to have more severe disease and are often more difficult to treat. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent when combined with standard-of-care corticosteroid nasal spray in patients with recurring severe CRSwNP despite previous treatment with surgery and/or systemic corticosteroids. About 60% of patients in the trials had co-morbid asthma.

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