Regeneron says FDA has extended approval of Praluent

Regeneron Pharmaceuticals announced the U.S. Food & Drug Administration has extended the approval of Praluent as an adjunct to diet and other low-density lipoprotein cholesterol lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia. The approval is based on a Phase 3, randomized multicenter trial evaluating pediatric patients aged 8 to 17 with HeFH, who had LDL-C levels of 130mg/dL or greater and were already being treated with lipid-lowering medications. Patients were randomized to receive Praluent or placebo every two or four weeks in two consecutive cohorts. Patients who received Praluent every four weeks had 31% lower LDL-C than placebo at 24 weeks. Improvements in additional key lipid parameters were also observed. Results from the trial were recently published in the Journal of the American Medical Association Pediatrics.