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Palynziq
Published
Product name
Palynziq
Active ingredient
Pegvaliase
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Palynziq (pegvaliase) was approved for the following therapeutic use:
Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control despite prior management with available treatment options.
How this medicine works
Pegvaliase is a pegylated recombinant phenylalanine ammonia lyase enzyme that converts phenylalanine to ammonia and cinnamic acid that are primarily eliminated by liver metabolism.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Palynziq was considered favourable for the therapeutic use approved.
ARTG details
N/A