Drug Profile


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

Latest Information Update: 15 Sep 2017

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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

  • Preregistration Phenylketonuria

Most Recent Events

  • 14 Sep 2017 US FDA is not planning to hold advisory committee meeting for the review of BLA of pegvaliase for Phenylketonuria
  • 30 Aug 2017 FDA assigns PDUFA action date of (28/02/2018) for pegvaliase for Phenylketonuria
  • 30 Aug 2017 Pegvaliase receives priority review status for Phenylketonuria in USA
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