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A study asessing AT-007 in pediatric patients

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Trial Profile

A study asessing AT-007 in pediatric patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2024

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At a glance

  • Drugs Govorestat (Primary)
  • Indications Galactosaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ACTION-Galactosemia Kids

    • Most Recent Events

    • 27 Nov 2024 According to an Applied Therapeutics media release, results of this study were published in the Journal of Clinical Pharmacology.
    • 27 Nov 2024 According to an Applied Therapeutics media release, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat for the treatment of Classic Galactosemia indicates that the FDA completed its review of the application and determined that it is unable to approve the NDA in its current form, citing deficiencies in the clinical application.
    • 07 Nov 2024 According to an Applied Therapeutics media release, the company has submitted MAA for govorestat for the treatment of Classic Galactosemia to the European Medicines Agency (EMA), which was validated in December 2023 and remains under review by the EMAs Committee for Medicinal Products for Human Use. The review remains within the Day 120 clock stop period and the Company expects a decision by the EMA early in the first quarter of 2025 supported by ACTIONGalactosemia Kids & ACTIONGalactosemia

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