Shots:
- The US FDA has granted accelerated approval to Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in pts (≥2yrs.) with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction, with commercial availability expected in Apr 2026
- Approval was based on the P-III (PEACE) trial assessing Loargys vs PBO, which showed reduced plasma arginine from baseline at 24wks.
- Additionally, Immedica is launching There for Rare, a patient support program offering nonmedical education & financial assistance guidance to enhance access for eligible individuals prescribed Loargys
Ref: PRnewswire | Image: Immedica | Press Release
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