BioMarin Pharmaceutical (BMRN) said late Friday the US Food and Drug Administration approved the company's supplemental biologics license application for Palynziq to include pediatric patients aged at least 12 years with phenylketonuria.
Palynziq is the only enzyme substitution therapy approved to lower blood phenylalanine concentrations in people with phenylketonuria, a rare metabolic disorder, the company said.