March 23, 2023: Dupixent (Dupilumab, SC)/ COPD/ Sanofi: Demonstrated significant reduction in acute exacerbation in the pivotal trial
Phase 3 trial comparing Dupixent to a placebo in adults with uncontrolled COPD & type 2 inflammation, met all primary and secondary endpoints
Dupixent is the first biologic to show a notable decrease (30%) in moderate or severe acute exacerbations as well as notable improvements in lung function, QOL, and COPD respiratory symptoms
Topline data expected in 2025
Trial Results:
30% reduction in moderate or severe acute COPD exacerbations
Improved lung function from baseline by 160 mL at 12 weeks compared to 77 mL for placebo, with the benefit versus placebo sustained through week 52
Overall AEs were 77%, for Dupixent vs 76% for placebo, with headache, diarrhea, and back pain being common
Another Phase 3 trial with Dupixent and Itepekimab (received fast-track designation from FDA for COPD in current non-smokers) is ongoing