Kuvan
What Kuvan is used for
Kuvan is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment. Kuvan is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Kuvan
- Active substance
- sapropterin
- Disease area
- Phenylketonurias
- Medicine group
- Other alimentary tract and metabolism products
- ATC code
- A16AX07
- Marketing authorisation holder
- BioMarin International Limited
- Authorised in the EU since
- 2008
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Kuvan used for?
Kuvan is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment. Kuvan is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.
What is the active substance in Kuvan?
Kuvan contains sapropterin.
Who makes Kuvan?
The EU marketing authorisation holder is BioMarin International Limited.
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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