BioMarin receives FDA approval for Palynziq
BioMarin received standard approval from the FDA for Palynziq™ (pegvaliase-pqpz), an enzyme replacement therapy to reduce blood phenylalanine (Phe) concentrations in adults with phenylketonuria (PKU). Palynziq™ is the first approved enzyme replacement therapy to target the underlying cause of PKU. Palynziq™ is BioMarin’s second approved treatment for this rare condition, and the company’s seventh approved product on the market to date. The approval of Palynziq™ in the US marks an important milestone for adults living with PKU who will now have access to an effective new treatment option for controlling their blood Phe.