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Monday, October 1, 2018
Aeglea BioTherapeutics gets rare pediatric disease tag on pegzilarginase
Aeglea BioTherapeutics gets rare pediatric disease designation on pegzilarginase Aeglea announced the FDA has granted rare pediatric disease designation to the company’s lead product candidate, pegzilarginase, for the treatment of Arginase 1 Deficiency. This designation by the FDA confirms Aeglea’s eligibility to receive a rare pediatric disease priority review voucher upon approval of a biologics license application for pegzilarginase. Arginase 1 Deficiency is a rare debilitating disease presenting in childhood with persistent hyperargininemia, severe progressive neurological abnormalities and early mortality. https://thefly.com/landingPageNews.php?id=2797675
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