Daiichi Sankyo's sNDA for cholesterol drug wins FDA approval

Thu. October 08, 2009; Posted: 01:13 PM

Oct 08, 2009 (Datamonitor via COMTEX) -- DSKYF | Quote | Chart | News | PowerRating -- Daiichi Sankyo Inc, the US subsidiary of Daiichi Sankyo Co, has reported that the FDA has approved the supplemental new drug application or sNDA for Welchol to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia alone or in combination with a statin after failing an adequate trial of diet therapy.

The approval of Welchol for pediatric patients with heterozygous familial hypercholesterolemia (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 3.75g/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.

According to Daiichi Sankyo, Welchol 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 low-density lipoprotein (LDL) cholesterol in adults with primary hyperlipidemia alone or in combination with a statin.

Evan Stein, director of Metabolic & Atherosclerosis Research Center, Cincinnati, Ohio, said: "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.

"The pivotal trial of Welchol in this pediatric patient population demonstrated that Welchol, as monotherapy or when combined with a statin, significantly reduced LDL-cholesterol."

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