FDA Approves Daiichi Sankyo’s sNDA For Welchol

The FDA has approved Daiichi Sankyo’s (DSI) supplemental new drug application 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.

Originally approved in 2000 for low-density lipoprotein cholesterol (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.

Reportedly, approval of Welchol for pediatric patients with heFH is based on data from an eight-week, multi-center, randomised, placebo-controlled clinical study, which evaluated the efficacy of Welchol tablets (1.875 or 3.75g/d) as monotherapy or in combination with a statin.

The company said that 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.