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

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

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

Click here to read full press release/ article | Ref: BioMarin | Image: Glassdoor

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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