BRIEF—BioMarin gains EU approval for Palynziq

BioMarin Pharmaceutical has won European approval for Palynziq (pegvaliase injection) as a therapy for certain people with phenylketonuria (PKU).

The decision, which was widely anticipated following a  positive recommendation from the European Medicines Agency’s advisory panel, makes the drug the first enzyme substitution therapy approved in Europe to target the underlying cause of PKU.

The US regulator approved Palynziq in May 2018. It is the firm’s second approved treatment for the rare genetic disease, after Kuvan (sapropterin dihydrochloride) in 2008.