PALYNZIQ FDA Approval 2026
New Hope for PKU: Adolescents 12+ Gain Access to Breakthrough Enzyme Therapy
In a significant expansion of treatment options for the metabolic disease community, the U.S. Food and Drug Administration (FDA) has approved PALYNZIQ® (pegvaliase-pqpz) for pediatric patients 12 years of age and older with Phenylketonuria (PKU). This supplemental approval, announced on February 27, 2026, marks PALYNZIQ as the only enzyme substitution therapy available for this younger…
