ACMG recommends maintaining blood Phe levels below 360 μmol/L (6 mg/dL) for patients with PKU2

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Get started todaySignificant blood Phe reduction is possible with PALYNZIQ

PALYNZIQ® (pegvaliase-pqpz) Injection is the first and only enzyme for PKU that can work in all eligible adult patients irrespective of genotype.1,2 Following a Phe-restricted diet* is not required in conjunction with PALYNZIQ
- At baseline, 57% of patients were taking medical food (149 of 261) and 16% were on a Phe-restricted diet (41 of 261)1

In clinical trials, 66% (57 of 86) of patients had blood Phe levels ≤360 µmol/L at 24 months. 50% (43 of 86) of the patients had blood Phe levels ≤120 µmol/L at 24 months1

10% (29 of 285) of patients experienced a total of 42 anaphylaxis episodes1
- The frequency of hypersensitivity reactions decreased over time from induction/titration to maintenance, despite increasing dose3
- Most common adverse reactions (at least 20% in either treatment phase) were: injection site reactions, arthralgia, hypersensitivity reactions, headache, generalized skin reactions lasting at least 14 days, nausea, abdominal pain, vomiting, cough, oropharyngeal pain, pruritus, diarrhea, nasal congestion, fatigue, dizziness, and anxiety1
A Phe-restricted diet is defined as >75% of protein intake from medical food.1
References: 1. PALYNZIQ [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2020. 2. Vockley J, Andersson HC, Antshel KM, et al; for the American College of Medical Genetics and Genomics Therapeutic Committee. Phenylalanine hydroxylase deficiency: diagnosis and management guideline. Genet Med. 2014;16(2):188-200. 3. Gupta S, Lau K, Harding CO, et al. Association of immune response with efficacy and safety outcomes in adults with phenylketonuria administered pegvaliase in phase 3 clinical trials. EBioMedicine. 2018;37:366-373.