Posted by Michael Wonder on 30 Aug 2017
FDA accepts BioMarin's pegvaliase biologics license application and grants priority review designation
29 August 2017 - BioMarin Pharmaceutical today announced that the U.S. FDA has accepted for priority review the biologics license application for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, to reduce blood phenylalanine levels in adult patients with phenylketonuria who have uncontrolled blood phenylalanine levels on existing management.
The PDUFA action date is 28 February 2018.
