Daiichi Sankyo drug Welchol approved by FDA

Daiichi Sankyo has revealed that its Heterozygous Familial Hypercholesterolemia (heFH) treatment Welchol (colesevelam HCI) has been authorised by the Food and Drug Administration (FDA) for the lowering of low-density lipoprotein (LDL) cholesterol in paediatric patients.

Welchol is recommended, alongside diet and exercise, for the reduction of LDL cholesterol in boys and postmenarchal girls aged between ten and 17 suffering from heFH alone or in combination with a statin after failing a trial of diet therapy.

Familial hypercholesterolemia is a genetic condition resulting in elevated LDL cholesterol and an increased risk of cardiovascular disease.

Evan Stein, director of the Metabolic and Atherosclerosis Research Centre, commented: “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.”

This news comes after Daiichi Sankyo, in partnership with Lilly, announced that it obtained approval for Effient (prasugrel) tablets from the FDA in July 2009.