Aeglea BioTherapeutics Submits BLA for Pegzilarginase as First Potential Treatment for Arginase 1 Deficiency
• Aeglea BioTherapeutics has submitted a Biologics License Application to the FDA for pegzilarginase with Priority Review request, potentially becoming the first approved treatment for Arginase 1 Deficiency.
• The Phase III PEACE trial demonstrated that pegzilarginase achieved an 80% reduction in plasma arginine levels, with 90.5% of treated patients reaching normal levels compared to none in the placebo group.
• If approved, analysts project pegzilarginase could achieve peak sales of $300-400 million, while European marketing authorization submission is planned for 2022 through partner Immedica Pharma AB.
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