FDA Grants Rare Pediatric Disease Designation to Pegzilarginase for Arginase 1 Deficiency
Aeglea BioTherapeutics, Inc. (AGLE)
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Source: GlobeNewswire
Aeglea Eligible to Receive a Priority Review Voucher Company Plans to Initiate Pivotal Trial in First Half of 2019 AUSTIN, Texas, Oct. 01, 2018 (GLOBE NEWSWIRE) -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, today announced the U.S. Food and Drug Administration (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 (PRV) upon approval of a biologics license application (BLA) for pegzilarginase. Arginase 1 Deficiency is a rare debilitating disease presenting in childhood with persistent hyperargininemia, severe progressive neurological abnormalities and early mortality. “This designation underscores the seriousnes
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