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Aeglea BioTherapeutics Announces European Medicines Agency Validation of Marketing Authorization Application for Pegzilarginase for the Treatment of Arginase 1 Deficiency
AUSTIN, Texas, Aug. 18, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of
About this update from Spyre Therapeutics, Inc.
[{"type":"text","content":"AUSTIN, Texas, Aug. 18, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today announced that a Marketing Authorization Application (MAA) for pegzilarginase for the treatment of Arginase 1 Deficiency (ARG1-D) has been submitted to and successfully validated by the European Medicines Agency (EMA). The MAA was submitted by Immedica Pharma AB, Aeglea's commercialization partner in Europe and the Middle East.\nPegzilarginase is a novel, recombinant human arginase 1 enzyme that in clinical trials has been shown to normalize the elevated levels of the amino acid arginine in patients with ARG1-D, a rare, progressive disease characterized by high levels of arginine. People living with ARG1-D experience severe spasticity-related mobility limitations, seizures, developmental delay, intellectual disability, and early mortality.\n\"For progressive diseases like ARG1-D, every day that passes without an approved therapy increases the disease burden and worsens the outcome for patients and their families. If approved, we believe pegzilarginase has the potential to benefit these families,\" said Anthony G. Quinn, M.B., Ch.B., Ph.D., president and chief executive officer of Aeglea. \"We are thrilled with the progress being made with the validation of the MAA and look forward to continuing to work with and support our partner Immedica throughout the EMA review process.\"\nDr. Quinn continued, \"I would like to thank all the patients, families, investigators, staff and advocates who participated in our clinical trials and helped in the advancement of pegzilarginase, potentially the first health authority-approved treatment to address the underlying driver of ARG1-D, elevated arginine levels.\"\nImmedica's MAA submission includes data from multiple clinical studies in ARG1-D, including the double-blind, placebo-controlled PEACE Phase 3 study and its ongoing long-term extension, a Phase 1/2 clinical trial and an open-label extension study. Results from these trials demonstrate that pegzilarginase is able to rapidly and sustainably lower arginine levels and showed improvements in measures of mobility. In the PEACE study, most treatment-emergent adverse events were mild or moderate in severity ...