Logo

BioMarin's Palynziq (pegvaliase injection) Receives European Commission's MAA Approval for Phenylketonuria

Share this

BioMarin's Palynziq (pegvaliase injection) Receives European Commission's MAA Approval for Phenylketonuria

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 & 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

Ref: BioMarin | Image: Glassdoor

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions