Regeneron (REGN) Gets FDA Nod for Praluent Label Extension
REGNRegeneron(REGN) Zacks Investment Research·2024-03-13 01:36

Regeneron Pharmaceuticals, Inc. (REGN) announced that the FDA extended the approval of the cholesterol drug Praluent’s (alirocumab) label. The regulatory body approved the drug as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged eight and older with heterozygous familial hypercholesterolemia (HeFH). The approval is based on a phase III, randomized multi-center trial evaluating pediatric patients aged 8 to 17 with HeFH, who had LDL ...