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FDA Approves Biomarin's (BMRN) Palynziq (pegvaliase-pqpz) Injection for Treatment of Adults with Phenylketonuria (PKU)

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Additional Information

Additional Relevant Details BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that BioMarin received standard approval from the U.S. Food and Drug Administration (FDA) for Palynziq™ (pegvaliase-pqpz) Injection to reduce blood phenylalanine (Phe) concentrations in adult patients with phenylketonuria (PKU), who have uncontrolled blood Phe concentrations greater than 600 micromol/L on existing management. Palynziq, a PEGylated recombinant phenylalanine ammonia lyase enzyme, is the first approved enzyme substitution therapy to target the underlying cause of PKU by helping the body to break down Phe. Palynziq is BioMarin's second approved treatment for this important condition.
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May 24, 2018
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Related Keywords Pegvaliase-pqpz, Palynziq, Phenylketonuria