BioMarin Receives FDA Approval for Palynziq in Patients 12 and Older
BioMarin Pharmaceutical announced that the U.S. Food and Drug Administration, FDA, has approved the company's supplemental Biologics License Application, sBLA, for Palynziq to include pediatric 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 PKU.