Is Pegvaliase approved by the US FDA?

Drugs@FDA lists 1 application product line for Pegvaliase, including PALYNZIQ (Prescription).

Is Pegvaliase authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Pegvaliase: Palynziq.

Are there safety signals or safety updates for Pegvaliase?

US FDA: 1 entry (latest 2026-02-27).

Active substance

Pegvaliase

US FDA 1
EMA 1
Health Canada 3
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PALYNZIQ	2.5MG/0.5ML; 10MG/0.5ML; 20MG/ML	injectable · injection	BIOMARIN PHARM	Prescription	24 May 2018

EMA European Union — centrally authorised medicines

Palynziq BioMarin International Limited · Authorised · authorised 3 May 2019 · ATC A16AB19

Therapeutic indication (EMA)

Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PALYNZIQ	02526247	2.5 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	BIOMARIN INTERNATIONAL LIMITED
PALYNZIQ	02526255	10 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	BIOMARIN INTERNATIONAL LIMITED
PALYNZIQ	02526263	20 MG / ML	SOLUTION · SUBCUTANEOUS	BIOMARIN INTERNATIONAL LIMITED

Safety signals and safety-related labeling changes

US FDA 27 Feb 2026 PALYNZIQ — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pegvaliase →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.