Sanofi: FDA approves priority review of Dupixent
(CercleFinance.com) - Sanofi announces that the US Food and Drug Administration (FDA) has granted priority consideration to Dupixent's (Dupilumab) application for approval of severe inadequately controlled severe chronic rhinosinusitis with nasal polyps.
The FDA is expected to render its decision on 26 June 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," the group said.
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.
Copyright (c) 2019 CercleFinance.com. All rights reserved.
The FDA is expected to render its decision on 26 June 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," the group said.
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.
Copyright (c) 2019 CercleFinance.com. All rights reserved.