FDA approves BioMarin's phenylketonuria drug

FDA approved Palynziq pegvaliase-pqpz from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) to treat phenylketonuria (PKU) in patients who have uncontrolled blood phenylalanine levels on current treatment.

The company expects to launch the drug by the end of June. BioMarin spokesperson Debra Charlesworth said the drug will have an annual wholesale acquisition cost (WAC) of $267,000, with an average annual net price of $192,000 after rebates. The label includes a boxed warning for anaphylaxis, and the drug is only available via a REMS. ...