EXDENSUR (GlaxoSmithKline Australia Pty Ltd)
Product name
EXDENSUR
Date registered
Evaluation commenced
Decision date
Approval time
245 (255 working days)
Active ingredients
depemokimab
Registration type
NCE/NBE
Indication
Asthma
EXDENSUR is indicated as add-on maintenance treatment of severe asthma in patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
EXDENSUR is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with CRSwNP inadequately controlled by systemic corticosteroids or surgery.