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Daiichi Sankyo Files sNDA for Diabetes

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Daiichi Sankyo, Inc. has filed an sNDA with the FDA for WelChol to improve glycemic control in patients with type 2 diabetes mellitus. If approved, WelChol would be the first LDL cholesterol-lowering drug that also improves glycemic control. WelChol has been shown to lower A1C in patients with type 2 diabetes mellitus. WelChol, when added to insulin, demonstrated a mean A1C reduction of 0.5% compared to placebo. In an additional WelChol study, the Glucose Lowering Effect Of WelChol Study (G...

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