Cipaglucosidase alfa

FDA Drug Profile

Cipaglucosidase alfa is listed in the FDA National Drug Code directory with 1 NDC code. Available dosage form: powder, for solution.

Drug Details

Generic Name
Cipaglucosidase alfa
Brand Names
N/A
Application Number
Sponsor
Wuxi Biologics Co., Ltd.
NDC Codes
1
Dosage Forms
POWDER, FOR SOLUTION
Routes
N/A
Active Ingredients
CIPAGLUCOSIDASE ALFA

Indications and Usage

1 INDICATIONS AND USAGE POMBILITI is indicated, in combination with Opfolda, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). POMBILITI 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 ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). ( 1 )