Daiichi Sankyo, Inc. (DSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol® (colesevelam HCl) to be used as an adjunct to diet and exercise for the reduction of elevated low-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 diet therapy. Originally approved in 2000 for LDL-C lowering and in 2008 for A1C reduction in adults, Welchol is approved as an adjunct to diet and exercise to reduce elevated LDL-C in adults with primary hyperlipidemia and improve glycemic control in adults with type 2 diabetes mellitus.
Familial hypercholesterolemia (FH) is a genetic disorder resulting in elevated LDL cholesterol and increased risk of cardiovascular disease (CVD). There are 10 million people with FH worldwide, the majority of whom have heFH.
"The FDA approval of Welchol for children with inherited high cholesterol provides another important treatment option for these children, whose elevated LDL cholesterol puts them at increased risk for cardiovascular disease, said Evan A. Stein, MD, PhD, Director, Metabolic & Atherosclerosis Research Center, Cincinnati, OH. "The pivotal trial of Welchol in this pediatric patient population demonstrated that Welchol, as monotherapy or when combined with a statin, significantly reduced LDL-C."