Regeneron Pharmaceuticals, Inc. (REGN) announced the FDA 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 was based on a phase 3, randomized multicenter trial.
"The approval of Praluent for the treatment of high cholesterol was a historic landmark achievement, as it was the first approved therapy targeting the genetically-validated PCSK9 target for heart disease," said George Yancopoulos, President and Chief Scientific Officer at Regeneron, and a principal inventor of Praluent.
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