Drug Profile


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

Latest Information Update: 20 May 2017

Price : $50

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

  • Phase III Phenylketonuria

Most Recent Events

  • 04 May 2017 BioMarin announces intention to submit BLA to US FDA for Phenylketonuria in the second quarter of 2017
  • 21 Mar 2016 BioMarin announces intention to submit BLA to US FDA in the end of 2016
  • 21 Mar 2016 Interim efficacy data and adverse events data from the phase III PRISM 302 trial in Phenylketonuria released by BioMarin
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