NEXVIAZYME (Sanofi-Aventis Australia Pty Ltd)
Product name
NEXVIAZYME
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
196 (255 working days)
Active ingredients
avalglucosidase alfa
Registration type
NCE/NBE
Indication
NEXVIAZYME (powder for injection) is indicated for long-term enzyme replacement therapy for the treatment of patients one year of age and older with Pompe disease (acid α-glucosidase deficiency).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.