PALYNZIQ™ (pegvaliase-pqpz) Injection is the first FDA-approved enzyme substitution therapy designed to address the underlying cause of phenylketonuria (PKU), a rare and genetic brain-threatening condition marked by an inability to break down phenylalanine (Phe). PALYNZIQ™ is a once-daily self-administered therapy, clinically proven to reduce blood Phe levels in adults with PKU who have uncontrolled blood Phe levels on existing management.
Left untreated, high levels of Phe can become toxic to the brain and may lead to serious neurological and neuropsychiatric-related issues, impacting the way a person thinks, feels, and acts. PKU requires daily lifelong management and affects just 350 US newborns each year.
PALYNZIQ is a PEGylated phenylalanine ammonia lyase (PAL) enzyme that helps to break down phenylalanine into ammonia and trans-cinnamic acid. PALYNZIQ substitutes for the deficient phenylalanine hydroxylase (PAH) enzyme in PKU patients to reduce the concentration of phenylalanine in the blood.
Other Questions About Phenylketonuria
- Will my child with phenylketonuria go through puberty the same time as their peers?
- Will my child with phenylketonuria be able to live independently?
- Will my child outgrow phenylketonuria?
- Will my child have to use medical food product for phenylketonuria for their entire life or just a period of time?
- Why is phenylketonuria considered an amino acid disorder?

