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Pegvaliase - BioMarin Pharmaceutical

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Drug Profile

Pegvaliase - BioMarin Pharmaceutical

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

Latest Information Update: 10 Nov 2025

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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

  • 29 Oct 2025 Preregistration for Phenylketonuria (In adolescents) in USA (SC)
  • 29 Oct 2025 BioMarin Pharmaceutical plans to submit regulatory filings for label expansion for Phenylketonuria (In adolescents) in European Union (SC, injection)
  • 29 Oct 2025 FDA assigns PDUFA action date of 28/02/26 for Pegvaliase for Phenylketonuria

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