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Palynziq Approval History

FDA Approved: Yes (First approved May 24, 2018)
Brand name: Palynziq
Generic name: pegvaliase-pqpz
Dosage form: Injection
Company: BioMarin Pharmaceutical Inc.
Treatment for: Phenylketonuria

Palynziq (pegvaliase-pqpz) is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria.

Development History and FDA Approval Process for Palynziq

DateArticle
May 24, 2018Approval FDA Approves Palynziq (pegvaliase-pqpz) for the Treatment of Adults with Phenylketonuria
Mar 23, 2016BioMarin Phase 3 Study of Pegvaliase for Phenylketonuria (PKU) Meets Primary Endpoint of Blood Phenylalanine (Phe) Reduction (p<0.0001)

Further information

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