OPFOLDA (Amicus Therapeutics Pty Ltd)
Product name
OPFOLDA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
186 (255 working days)
Active ingredients
miglustat
Registration type
EOI
Indication
OPFOLDA (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset Pompe disease (acid α-glucosidase [GAA] deficiency).