Posted by Michael Wonder on 04 Mar 2019
BioMarin receives positive CHMP opinion in Europe for Palynziq (pegvaliase injection) for treatment of patients with phenylketonuria aged 16 and older
1 March 2019 - Decision on marketing authorisation application expected Q2 '19.
BioMarin Pharmaceutical announced today that the CHMP, the scientific committee of the EMA, has adopted a positive opinion for the company's marketing authorisation application for Palynziq (pegvaliase) Injection to reduce blood phenylalanine (Phe) concentrations in patients with phenylketonuria aged 16 and older, who have inadequate blood Phe control (blood Phe levels greater than 600 micromol/L) despite prior management with available treatment options.
In addition, the CHMP noted that the data collected in the Phase 3 trial and extension study was suggestive of an improvement in inattention and mood symptoms.
