Inclusion/Exclusion Criteria

Note that in the following sections the term “Investigator” includes CRP, CCA and/or PI.

Number of Participants and Participant Selection

This study will enroll pregnant women diagnosed with PKU who have been treated with pegvaliase from 2 weeks prior to LMP or at any time during pregnancy. As any pregnant women with PKU treated with pegvaliase are encouraged to participate in this study, the number of participants is not pre-determined.

Participants with completed pregnancies (i.e., pregnancy outcome is known prior to enrollment in the study) will not be included in the study. Participants who have undergone prenatal ultrasound/testing, regardless of findings, may enroll as long as their pregnancy is ongoing.

Inclusion Criteria

• Participant (or a legally authorized representative) consent obtained prior to enrollment. Consent will be obtained in compliance with any country-specific regulations or requirements
• Confirmation of ongoing pregnancy. Participants with unknown outcomes will be classified as prospective pregnancies; participants who have undergone prenatal testing (eg, targeted ultrasound, amniocentesis) regardless of findings will be classified as retrospective pregnancies
• Diagnosed with PKU per local standard of care
• Documentation that the participant was treated with pegvaliase at any point starting from 2 weeks prior to the date of last menstrual period (LMP)
• Agrees to permit the Investigator (i.e., CRP, CCA, PI) to contact the participant’s HCPs (e.g., PCP, PKU-treating physician, OB, nurse, midwife) and the infant’s HCP (e.g., pediatrician, neonatologist) for medical information

Exclusion Criteria

• Currently participating in a BioMarin interventional study of any investigational product, device, or procedure