Sanofi and Regeneron’s Dupixent Secures Historic FDA Approval as First Biologic Treatment for COPD

FDA Approval:
The FDA has approved Dupixent (dupilumab) as the first biologic treatment for chronic obstructive pulmonary disease (COPD), specifically for adults with inadequately controlled COPD and an eosinophilic phenotype.

Clinical Trials:
The approval is based on two Phase 3 trials, BOREAS and NOTUS, which demonstrated significant reductions in moderate or severe COPD exacerbations (30% and 34% respectively) and improvements in lung function and quality of life metrics.

Mechanism of Action:
Dupixent works by inhibiting IL-4 and IL-13 signaling pathways, which drive type 2 inflammation in COPD.

Market Impact:
Analysts predict that the COPD indication could add $3.5 billion to Dupixent’s peak sales potential, pushing it into the $20 billion range by the end of this decade.

Global Approvals:
Dupixent has also received approval for COPD in the European Union and China, marking a significant advancement in the treatment landscape for this condition.

Competition:
Other biologic treatments, such as GSK’s Nucala, are in late-stage trials for COPD, indicating potential future competition.