U.S. Food and Drug Administration Approves BioMarin's PALYNZIQ® (pegvaliase-pqpz) for Adolescents 12 Years of Age and Older with Phenylketonuria (PKU)

Treatment with PALYNZIQ led to statistically significant blood phenylalanine (Phe) lowering compared to diet alone in pivotal Phase 3 PEGASUS study PALYNZIQ is the only enzyme substitution therapy approved for the treatment of people with PKU SAN RAFAEL, Calif., Feb. 27, 2026 /PRNewswire/...