BioMarin’s Palynziq (pegvaliase-pqpz) Receives FDA Approval for Phenylketonuria (PKU) in Adults

 BioMarin’s Palynziq (pegvaliase-pqpz) Receives FDA Approval for Phenylketonuria (PKU) in Adults

BioMarin Reports Results of Brineura (cerliponase alfa) for Patients with CLN2 Disease Aged 3 to 16 yrs.

Shots:

  • The approval is based on P-III PRISM-2 study results assessing Palynziq (pegvaliase-pqpz, 20mg qd or 40mg qd) in patients in ratio (2:1) with high level of phenylalanine (Phe)
  • The P-III PRISM-2 study resulted in maintaining blood Phe level vs PBO in patients
  • Palynziq (pegvaliase-pqpz, SC) is an enzyme substitution therapy of phenylalanine hydroxylase (PAH) enzyme helping in breaking down of Phe

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

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

Related post