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Cipaglucosidase alfa - Amicus Therapeutics

Drug Profile

Cipaglucosidase alfa - Amicus Therapeutics

Alternative Names: AT B200; cipaglucosidase alfa-atga; Pombiliti; Recombinant-human-acid-alpha-glucosidase-enzyme-Amicus; rhGAA-Amicus

Latest Information Update: 06 Mar 2024

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At a glance

  • Originator Amicus Therapeutics
  • Class Alpha-glucosidases; Enzymes
  • Mechanism of Action Alpha glucosidase replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Glycogen storage disease type II
  • New Molecular Entity No

Highest Development Phases

  • Registered Glycogen storage disease type II

Most Recent Events

  • 31 Dec 2023 Cipaglucosidase alfa - Amicus Therapeutics receives Orphan Drug status for Glycogen storage disease type II in United Kingdom, prior to December 2023
  • 28 Sep 2023 POMBILITI (cipaglucosidase alfa-atga) has a boxed warning for hypersensitivity reactions, infusion-associated reactions and risk of acute cardiorespiratory failure
  • 28 Sep 2023 Registered for Glycogen storage disease type II (Combination therapy) in USA (IV)
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