What age range of pku patients were included in sapropterin trials?

What age range of PKU patients were included in sapropterin trials?

Across sapropterin (Kuvan) clinical trials in phenylketonuria (PKU), enrolled participants included children and adults, with ages ranging from 4 years to 60 years [1].

Were younger children (below 4 years) included?

The commonly reported PKU trial age window for sapropterin use is 4 to 60 years, so the provided trial inclusion range does not include children younger than 4 years [1].

Does the age range differ by study type (e.g., classic vs. mild hyperphenylalaninemia)?

The cited trial inclusion range is the overall PKU trial range (4 to 60 years) [1], rather than a different range broken out by PKU severity in the available information.

Sources:
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021437s034lbl.pdf