Posted by Michael Wonder on 01 Mar 2026
US FDA approves BioMarin’s Palynziq (pegvaliase-pqpz) for adolescents 12 years of age and older with phenylketonuria
27 February 2026 - BioMarin today announced that the US FDA has approved the company's supplemental biologics license application for Palynziq (pegvaliase-pqpz) to include paediatric patients 12 years of age and older with phenylketonuria.
Palynziq is the only enzyme substitution therapy approved to reduce blood phenylalanine concentrations in people with phenylketonuria.
