- 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 & 1164 µmol/L); reduction in blood Phe level, @12mos.& @24mos. (1233 to 565 & 345 µmol/L); @36mos. maintained blood Phe level (341 µmol/L); improvement in inattention and mood symptoms
- Palynziq (pegvaliase injection, SC, qd) is PEGylated recombinant substitute of phenylalanine hydroxylase enzyme, administered at a dose up to 60mg and has received FDA’s approval for the reduction of Phe level in patients with PKU (Phe level> 600 µmol/L) in May’18
Click here to read full press release/ article | Ref: BioMarin | Image: Glassdoor