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Compassionate use clinical study of Eladocagene exuparvovec

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Trial Profile

Compassionate use clinical study of Eladocagene exuparvovec

Status: Completed
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 22 Jul 2022

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At a glance

  • Drugs Eladocagene exuparvovec (Primary)
  • Indications Aromatic amino acid decarboxylase deficiency; Inborn error amino acid metabolic disorders
  • Focus Expanded access; Registrational; Therapeutic Use

Most Recent Events

  • 20 Jul 2022 According to a PTC Therapeutics media release, Upstaza™ (eladocagene exuparvovec) was granted marketing authorization by the European Commission for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency in patients 18 months and older and marketing authorization is applicable to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein.
  • 20 May 2022 According to a ClearPoint Neuro media release, company received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending eladocagene exuparvovec (Upstaza) for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency in patients 18 months and older.
  • 21 Apr 2022 New trial record

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