Pegvaliase - BioMarin Pharmaceutical

Drug Profile

Pegvaliase - BioMarin Pharmaceutical

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

Latest Information Update: 03 Apr 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

  • Preregistration Phenylketonuria

Most Recent Events

  • 28 Mar 2018 Preregistration for Phenylketonuria in European Union (SC)
  • 22 Dec 2017 PDUFA action date extended by US FDA to 25/05/2018 for pegvaliase's BLA for Phenylketonuria
  • 18 Oct 2017 BioMarin Pharmaceutical announces intention to submit MAA in the EU for Phenylketonuria, in the first quarter of 2018
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