Posted by Michael Wonder on 09 Oct 2020
BioMarin receives FDA approval of label expansion to allow maximum dose of 60 mg for Palynziq (pegvaliase-pqpz) injection for treatment of adults with PKU
7 October 2020 - New safety and efficacy data out to 3 years for first and only enzyme therapy to treat PKU demonstrate phenylalanine lowering and support well characterised safety profile.
BioMarin today announced that the U.S. FDA has approved the supplemental biologics license application to increase the maximum allowable dose of 60 mg with Palynziq (pegvaliase-pqpz) Injection for treatment of adults with phenylketonuria.
Previously, the maximum dose was 40 mg. In the Phase 3 PRISM studies, 19% of study participants required a 60 mg dose to achieve adequate response to Palynziq.
