Daiichi Sankyo, Inc., has announced the approval of its supplemental New Drug Application (sNDA) for colesev-elam HCl (Welchol) to be used as an adjunct to diet and exercise, as mono-therapy or with a statin, to reduce elevated low-density lipoprotein-cholesterol (LDL-C) levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia who have not responded to a trial of diet therapy.
The approval was based on data from a study of doses of 1.875 or 3.75 g/day as monotherapy or with a statin. The tablets were originally approved in 2000 for lowering LDL-C levels and in 2008 for reducing glycosylated hemoglobin (HbA1c) in adults with type-2 diabetes drugs.
Colesevelam is not indicated for those patients with type-1 diabetes or diabetic ketoacidosis or for children with type-2 diabetes. It has not been studied in children younger than 10 years of age or in girls who have not attained menarche.
Source: Daiichi Sankyo, October 7,