This medicine is now known as pegvaliase.
On 28 January 2010, orphan designation (EU/3/09/708) was granted by the European Commission to BioMarin Europe Ltd, United Kingdom, for pegylated recombinant phenylalanine ammonia lyase for the treatment of hyperphenylalaninaemia.
The sponsorship was transferred to BioMarin International Limited, Ireland, in August 2016.
Pegylated recombinant phenylalanine ammonia lyase has been authorised in the EU as Palynziq since 3 May 2019.
Pegylated recombinant phenylalanine ammonia lyase (pegvaliase)
|Disease / condition||
Treatment of hyperphenylalaninaemia
|Date of first decision||
|EU designation number||
Review of designation
More information is available in the orphan medicine assessment report Palynziq : Orphan maintenance assessment report (initial authorisation) .
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.