Immedica’s Loargys Received positive opinion from EU’s CHMP to treat arginase-1 deficiency (ARGI-D)
Shots:
- The positive opinion was based on a P-III study (PEACE) evaluating Pegzilarginase vs PBO to treat ARGI-D in patients 2yrs older & above
- 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
- Loargys (Pegzilarginase) a new recombinant human enzyme, showed enhanced clinical outcomes by quickly and persistently lowering plasma levels of the amino acid arginine and its hazardous byproducts
Ref: Immedica | Image: Immedica
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
