XENPOZYME (Sanofi-Aventis Australia Pty Ltd)
Product name
XENPOZYME
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
110 (120 working days)
Active ingredients
olipudase alfa
Registration type
NCE/NBE
Indication
Xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in paediatric and adult patients with type A/B (Niemann-Pick type A/B) or type B (Niemann-Pick type B).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.