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Daiichi Sankyo files supplemental NDA for WelChol

Daiichi Sankyo Inc has filed a supplemental new drug application with the FDA for cholesterol drug WelChol to improve glycemic control in patients with type 2 diabetes.

The US subsidiary of Japanese pharmaceutical company Daiichi Sankyo said that, if approved, WelChol will be the first LDL cholesterol-lowering medication also indicated for improving glycemic control.

Clinical studies have shown that WelChol lowers A1C in patients with type 2 diabetes mellitus, according to the company, including one recently presented at the American Heart Association’s Scientific Sessions 2006 in Chicago.

Joseph Pieroni, president and CEO of Daiichi Sankyo Inc, said: “Given the prevalence of type 2 diabetes and high cholesterol and the number of patients who are not reaching goal, adding WelChol expands patients’ treatment options.”