Posted by Michael Wonder on 23 Feb 2024
Dupixent (dupilumab) sBLA accepted for FDA priority review for treatment of COPD with type 2 inflammation
23 February 2024 - Priority review granted based on positive results from two Phase 3 trials; if approved, Dupixent would be the only biologic therapy for COPD and the first new treatment approach for this disease in more than a decade.
Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has accepted for priority review the supplemental biologics license application for Dupixent (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease.
