FDA approves Daiichi Sankyo's sNDA for Welchol

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."

The approval of Welchol for pediatric patients with heFH is based on data from an eight-week, multi-center, randomized, placebo-controlled clinical study, which evaluated the efficacy of Welchol tablets (1.875 or 3.75 g/d) as monotherapy or in combination with a statin. The study was conducted with boys and postmenarchal girls 10-17 years of age, who were either treatment naive or on stable background statin therapy.

Welchol for Oral Suspension

The FDA also approved Welchol® (colesevelam HCl) for Oral Suspension, providing an alternative to the current tablet formulation. Welchol for Oral Suspension is indicated as an adjunct to diet and exercise to improve both glycemic control in adults with type 2 diabetes mellitus, and to reduce elevated LDL cholesterol in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with a hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (a statin). Welchol for Oral Suspension is also indicated for use as an adjunct to diet and exercise for the reduction of elevated LDL-C in boys and post-menarchal girls, 10 to 17 years of age, with heFH alone or in combination with a statin after failing an adequate trial of diet therapy. The recommended dose of Welchol for Oral Suspension is one 3.75 gram packet once daily.