U.S. License Holder:
Amicus Therapeutics US
Date of License:
September-28-2023
Last Update:
Nov-15-2024
FDA-Approved Indications
POMBILITI (cipaglucosidase alfa-atga) is a hydrolytic lysosomal glycogen-specific enzyme indicated, in combination with Opfolda, an enzyme stabilizer, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing greater than or equal to 40 kg and who are not improving on their current enzyme replacement therapy (ERT).
