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Daiichi-Sankyo gains FDA sNDA for Welchol

The US FDA has approved a supplemental new drug application for Daiichi-Sankyo's cholesterol drug Welchol

The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Daiichi-Sankyo's cholesterol drug Welchol.

The sNDA allows Welchol (colesevelam HCl) to be for the reduction of elevated low-density lipoprotein cholesterol (LDL-C), used as an adjunct to diet and exercise, in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH). The drug can be used alone or in addition to a statin once an adequate trial of diet therapy has been tried and failed.

"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 Dr Evan A. Stein, director, Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio. "The pivotal trial of Welchol in this paediatric patient population demonstrated that Welchol, as monotherapy or when combined with a statin, significantly reduced LDL-C."

Welchol was approved in 2000, as an adjunct to diet and excerices, as a treatment to lower LDL-C cholesterol in adults with primary hyperlipidemia and to improve glycemic control in adults with type 2 diabetes mellitus. In 2008 it was approved to lower A1C in adults.

12th October 2009

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