Daiichi Sankyo submits sNDA for WelChol

Japanese drug major Daiichi Sankyo has filed a supplemental New Drug Application with the US Food and Drug Administration for WelChol (colesevelam HCl) as a drug to improve glycemic control in patients with type 2 diabetes. If approved, the agent will be the first cholesterol-lowering medication also cleared for this indication. Clinical studies have shown that WelChol lowers HbA1C in these patients. A study presented at the American Heart Association's 2006 meeting, showed that WelChol plus insulin demonstrated a mean HbA1C reduction of 0.5% compared to placebo (-0.41% versus +0.09%, p<0.007).