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Pegvaliase - BioMarin Pharmaceutical

Drug Profile

Pegvaliase - BioMarin Pharmaceutical

Alternative Names: BMN-165; Palynziq; PEG-PAL; PEGylated phenylalanine ammonia lyase; Pegylated recombinant Anabaena variabilis phenylalanine ammonia lyase; PEGylated recombinant phenylalanine ammonia lyase; Phenylase; rAvPAL-PEG

Latest Information Update: 20 Nov 2018

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At a glance

  • Originator IBEX Technologies
  • Developer BioMarin Pharmaceutical
  • Class Ammonia lyases; Enzymes; Recombinant proteins
  • Mechanism of Action Phenylalanine ammonia lyase replacements
  • Orphan Drug Status

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

    Yes - Phenylketonuria
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Phenylketonuria

Most Recent Events

  • 07 Jan 2019 BioMarin Pharmaceutical anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) for Phenylketonuria in the first quarter of 2019
  • 07 Jan 2019 BioMarin Pharmaceutical anticipates approval from the European Commission (EC) for Phenylketonuria in the second quarter of 2019
  • 20 Nov 2018 BioMarin Pharmaceutical plans a phase III trial for Phenylketonuria (second line therapy or grater)(in adults) in Austria, France, Germany, Italy, Netherlands, Spain, Turkey (EudraCT2018-000648-25)
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