Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of COPD with Type 2 Inflammation
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 Regulatory submissions are also under review in China and Europe Dupixent is the leading biologic treatment for all five of its FDA-approved indications in new-to-brand prescriptions in the U.S. TARRYTOWN, N.Y. and PARIS, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals,