Aeglea BioTherapeutics Receives FDA Breakthrough Therapy Designation for Pegzilarginase for Treatment of Arginase 1 Deficiency
Aeglea BioTherapeutics, Inc. (AGLE)
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Source: GlobeNewswire
AUSTIN, Texas, July 24, 2019 (GLOBE NEWSWIRE) -- Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company that engineers next-generation human enzymes to provide solutions for diseases with unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to the Company’s lead investigational therapy, pegzilarginase, for the treatment of Arginase 1 Deficiency (ARG1-D), a rare progressive disease presenting in early childhood that results in severe complications and early mortality. "The emerging clinical data demonstrating favorable effects of pegzilarginase treatment on both plasma arginine levels and important disease manifestations has led to the FDA’s designation of pegzilarginase as a breakthrough therapy," said Anthony G. Quinn, M.B. Ch.B, Ph.D., president and chief executive officer of Aeglea. “Breakthrough Therapy Designation provides a path to work closely with the FDA as we qu
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