DUPIXENT (Sanofi-Aventis Australia Pty Ltd)
Product name
DUPIXENT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
219 (255 working days)
Active ingredients
dupilumab
Registration type
EOI
Indication
Asthma
DUPIXENT (for injection pre-filled syringe with needle shield) is now also indicated as add on maintenance treatment in patients aged 6 years and older with moderate to severe asthma with type 2 inflammation (elevated eosinophils or elevated FeNO) that is inadequately controlled despite therapy with other medicinal products for maintenance treatment (see Section 5.1 Pharmacodynamic Properties – Clinical Trials).