We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
DUPIXENT (Sanofi-Aventis Australia Pty Ltd)
Product name
DUPIXENT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
165 (255 working days)
Active ingredients
dupilumab
Registration type
EOI
Indication
Chronic obstructive pulmonary disease
Dupixent is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a stable combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available