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Cipaglucosidase alfa - Amicus Therapeutics

Drug Profile

Cipaglucosidase alfa - Amicus Therapeutics

Alternative Names: AT GAA; AT-B200/AT-2220; ATB 200+chaperone; ATB-200; ATB200/AT2221; Recombinant-human-acid-alpha-glucosidase-enzyme-Amicus; rhGAA-Amicus

Latest Information Update: 03 Feb 2020

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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 Yes

Highest Development Phases

  • Phase III Glycogen storage disease type II

Most Recent Events

  • 09 Jan 2020 Amicus Therapeutics completes enrolment in its phase I/II trial for Glycogen storage disease type II in United Kingdom, Australia, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Canada, Denmark, France, Germany, Greece, Hungary, Italy, Japan, South Korea, Poland, Netherlands, Slovenia, Spain, Taiwan, Sweden, USA, Argentina((NCT02675465)
  • 07 Jan 2020 Amicus Therapeutics plans to file a rolling BLA for Glycogen storage disease II (Pompe disease) in the first half of 2021
  • 07 Jan 2020 The British Medicines and Healthcare products Regulatory Agency (MHRA) issues a Promising Innovative Medicine (PIM) designation for Glycogen storage disease type II(Pompe disease)
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