Immedica intends to re-submit the BLA seeking approval of Loargys® (pegzilarginase) for treatment of arginase 1 deficiency (ARG1-D) in the US
Stockholm, December 21, 2023: Immedica today announces its intention to re-submit the biologics license application (BLA) seeking approval of Loargys® (pegzilarginase) for the treatment of arginase 1 deficiency (ARG1-D) in the US during 2024. The decision was taken following the recent approval of Loargys by the European Commission on December 15 and after a dialogue with the FDA. About Loargys®Loargys (pegzilarginase) is a novel recombinant human enzyme and has been shown to rapidly and sustainably lower levels of the amino acid arginine and its toxic metabolites in plasma