EU approves Plynziq (pegvaliase injection) to reduce phenyl-amino in blood in people with phenyl-acetonuria
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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today, BioMarin Pharmaceuticalcompany(http:// announcedthat the European Union has approved the launch of Peglynziq (pegvaliase injection) to reduce levels of phenylanine (Phe) in the blood of people over the age of 16 with phenylacetosterone (PKU)The Levels of Phe in the blood of these patients were not adequately controlled, even with other treatmentsPalynziq is a polyglycolated phenylalanine aminesinase (PAL), the first approved enzyme replacement therapy in Europe to target the PKU pathology mechanismPalynziq is a polyglycolated phenylalanine deaminase that reduces Phe levels in a patient's blood to the target range by degrading PheThe EU's approval of Palynziq is based on the results of its clinical development project, which includes a Phase 3 ClinicalTrial(http://called PRISM-2the results of this trial showed that patients treated with palynziq at a dose of 20 mg or 40 mg were able to maintain blood Phe levels at 553.0 ?mol/L and 566.3 ?mol/L after 8 weeksThe levels of the 20 mg or 40 mg placebo control group were 1509.0 smol/L and 1164.0 smol/LIn a 36-month open label extension study, blood Phe levels in patients using Palynziq were consistently reducedThe average Phe level was reduced from 1233 to 565 smol/L (12th month, n?164), 345 smol/L (24th month, n?90), and 341 smol/L (36th month, n?48)After 36 months, 72% of patients met the EU-recommended treatment target (Phe level slower than 600 ?mol/L)
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