FDA grants Aeglea's confirmation of the drug pegzilarginase breakthrough therapy
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Last Update: 2020-06-08
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Source: Internet
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Author: User
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ARG1-D, also known as arginineemia, is a rare genetic disorderPatients due to mutations in the ARG1 gene, resulting in the lack of argininase 1 in the liver, arginine metabolism disordersAeglea BioTherapeutics(http:// announcedthat the U.SFDA(http://has granted its research treatment, Pegzilarginase Breakthrough Therapy, to treat arginine deficiency (ARG1-D)The FDA's GroundBreaking Therapy Designation sought to accelerate the development and review of innovative therapiesPegzilarginase is an enhanced body arginine enzyme that promotes the metabolism of arginine in the bodyThis enzyme replacement therapy can reduce the level of arginine in the patient's blood, to achieve the therapeutic effectThe 1/2 ClinicalTrial(http://and Phase 2 Open Label Extension Trial data show that blood argine levels decreased and remained stable in patients after pegzilarginase administrationAeglea is now preparing for a key Phase 3 clinical trial designed to compare the effects of pegzilarginase treatment with placebo treatment
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