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DUPIXENT (Sanofi-Aventis Australia Pty Ltd)

Product name
DUPIXENT
Sponsor
Sanofi-Aventis Australia Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
172 (255 working days)
Active ingredients
dupilumab
Registration type
EOI
Indication

Dupixent is indicated for the following type 2 inflammatory diseases:

Atopic Dermatitis

Adults and adolescents

Dupixent is indicated for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older who are candidates for chronic systemic therapy. Dupixent is not intended for episodic use.

Children 6 to 11 years of age

Dupixent is indicated for the treatment of severe atopic dermatitis in patients aged 6 to 11 years old who are candidates for chronic systemic therapy. Dupixent is not intended for episodic use.

Prurigo Nodularis

Dupixent is indicated for the treatment of moderate-to-severe prurigo nodularis (PN) in adults who are candidates for systemic therapy.

Asthma

Dupixent is 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).

Chronic rhinosinusitis with nasal polyposis (CRSwNP)

Dupixent is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

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