Pegvaliase: Difference between revisions
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| tradename = Palynziq |
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| Drugs.com = {{drugs.com|monograph|pegvaliase-pqpz}} |
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| CAS_number = 1585984-95-7 |
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| StdInChI=1S/C15H30N2O5/c1-21-11-12-22-10-6-2-3-8-14(18)17-9-5-4-7-13(16)15(19)20/h13H,2-12,16H2,1H3,(H,17,18)(H,19,20)/t13-/m0/s1 |
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'''Pegvaliase''' |
'''Pegvaliase''', sold under the brand name '''Palynziq''', is a medication for the treatment of the genetic disease [[phenylketonuria]].<ref name=FDA2018Sub/> Chemically, it is a [[pegylated]] [[derivative (chemistry)|derivative]] of the enzyme [[phenylalanine ammonia-lyase]] that metabolizes [[phenylalanine]] to reduce its blood levels.<ref>{{Cite web | url = https://www.palynziq.com/hcp/ | title = Palynziq | publisher = BioMarin Pharmaceutica}}</ref> |
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It was approved by the [[Food and Drug Administration]] for use in the United States in 2018.<ref name=FDA2018Sub>{{cite |
It was approved by the [[Food and Drug Administration]] for use in the United States in 2018.<ref name=FDA2018Sub>{{cite press release | url = https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pku-rare-and-serious-genetic-disease | title = FDA approves a new treatment for PKU, a rare and serious genetic disease | publisher = [[Food and Drug Administration]] | date = May 24, 2018}}</ref> The U.S. [[Food and Drug Administration]] (FDA) considers it to be a first-in-class medication.<ref>{{cite report | title=New Drug Therapy Approvals 2018 | website=U.S. [[Food and Drug Administration]] (FDA) | date=January 2019 | url=https://www.fda.gov/media/120357/download | format=PDF | access-date=16 September 2020}}</ref> |
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==References== |
==References== |
Revision as of 07:54, 12 October 2020
Clinical data | |
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Pronunciation | peg val' i ase |
Trade names | Palynziq |
Other names | Pegvaliase-pqpz; PEG-PAL; RAvPAL-PEG |
AHFS/Drugs.com | Monograph |
MedlinePlus | a618057 |
Routes of administration | Subcutaneous injection |
ATC code | |
Legal status | |
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Pegvaliase, sold under the brand name Palynziq, is a medication for the treatment of the genetic disease phenylketonuria.[2] Chemically, it is a pegylated derivative of the enzyme phenylalanine ammonia-lyase that metabolizes phenylalanine to reduce its blood levels.[3]
It was approved by the Food and Drug Administration for use in the United States in 2018.[2] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[4]
References
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
- ^ a b "FDA approves a new treatment for PKU, a rare and serious genetic disease" (Press release). Food and Drug Administration. May 24, 2018.
- ^ "Palynziq". BioMarin Pharmaceutica.
- ^ New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Retrieved 16 September 2020.
External links
- "Pegvaliase". Drug Information Portal. U.S. National Library of Medicine.