Regulatory
BioMarin’s Palynziq (pegvaliase injection) Receives European Commission’s MAA Approval for
Shots: The approval is based on P-III PRISM-2 study results assessing Palynziq (pegvaliase injection, 20 & 40 mg) vs PBO in 215 PKU patients with inadequate blood Phe level >600 micromol/L aged >16 followed by an extension study @36mos. The collective results: @8wks. maintained mean blood Phe levels (553.0 & 566.3 µmol/L vs 1509.0 & […]Read More
