Posted by Michael Wonder on 23 Dec 2017
BioMarin receives anticipated notification of PDUFA extension for pegvaliase biologics license application to 28 May 2018
22 December 2017 - Regulatory review process proceeding in-line with company's expectations.
BioMarin today announced that the U.S. FDA will require additional time to complete its review of the biologics license application for its investigational therapy pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, to reduce blood phenylalanine (Phe) levels in adult patients with phenylketonuria who have uncontrolled blood Phe levels on existing management.
In a notice received from the FDA, the Prescription Drug User Fee Act goal date for pegvaliase has been extended by three months to 28 May 2018. Due to the Memorial Day weekend, the Action Goal Date will be 25 May 2018.
