Welchol Receives FDA Approval to Lower LDL Cholesterol in Pediatric Patients
Wed, 10/07/2009 - 4:30am
Daiichi Sankyo, Inc. (DSI)announced today that the FDA has approvedthe supplemental new drug application (sNDA) for Welchol (colesevelam HCl) tobe used as an adjunct to diet and exercise for the reduction of elevatedlow-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls,10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH)alone or in combination with a statin after failing an adequate trial of diettherapy. Originally approved in 2000 for LDL-C lowering and in 2008 for A1Creduction in adults, Welchol is approved as an adjunct to diet and exercise toreduce elevated LDL-C in adults with primary hyperlipidemia and improveglycemic control in adults with type 2 diabetes mellitus. Familial hypercholesterolemia (FH) is a genetic disorder resulting inelevated LDL cholesterol and increased risk of cardiovascular disease(CVD).(1) There are 10 million people with FH worldwide, the majority of whomhave heFH.(2) "The FDA approval of Welchol for children with inherited high cholesterolprovides another important treatment option for these children, whose elevatedLDL cholesterol puts them at increased risk for cardiovascular disease…," saidEvan A. Stein, MD, PhD, Director, Metabolic & Atherosclerosis Research Center,Cincinnati, OH. "The pivotal trial of Welchol in this pediatric patientpopulation demonstrated that Welchol, as monotherapy or when combined with astatin, significantly reduced LDL-C."