FDA to Undertake Priority Review of Dupixent® (dupilumab) for Adults with Inadequately Controlled Severe Chronic Rhinosinusitis with Nasal Polyps

TARRYTOWN, N.Y. and PARIS, March 8, 2019 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food an

Source: www.prnewswire.com

The U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Regeneron Pharmaceuticals and Sanofi’s drug Dupixent. This drug would be an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP). 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.