Aeglea BioTherapeutics Reports the Validation of EMA's MAA for Pegzilarginase to Treat Arginase 1 Deficiency
Shots:
- The EMA has validated the MAA for pegzilarginase to treat ARG1-D which was submitted by Immedica Pharma AB & Aeglea's commercialization partner in the EU and the Middle East
- The MAA was based on multiple clinical studies incl. P-III (PEACE) study and its ongoing long-term extension, P-I/II clinical trial & OLE study to evaluate pegzilarginase in patients with ARG1-D
- The P-III (PEACE) trial met its 1EPs i.e., 76.7% reduction in mean plasma arginine over PBO, 90.5% achieved normal plasma arginine levels, and no discontinuations due to TRAEs while the P-I/II & P-II OLE study results showed clinical improvements, sustained lowering of plasma arginine & improvements in measures of mobility
Ref: PRNewswire | Image: Aeglea BioTherapeutics
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