DAIICHI SANKYO FILES SNDA FOR WELCHOL IN TYPE 2 DIABETES

Daiichi Sankyo has filed a supplemental new drug application (sNDA) with the FDA for WelChol (colesevelam HCl) to improve glycemic control in patients with Type 2 diabetes. If approved, WelChol will be the first cholesterol-lowering medication also indicated for improving glycemic control.

Clinical studies have shown that WelChol lowers A1C in patients with Type 2 diabetes. One study, presented at the American Heart Association's Scientific Sessions 2006, showed that WelChol, when added to insulin, demonstrated a mean A1C reduction of 0.5 percent compared with placebo. A similar effect was demonstrated in another study in which WelChol added to an oral antidiabetic therapy also resulted in mean A1C reductions of 0.5 percent compared with placebo and 1.0 percent in patients with A1C greater than or equal to 8.0 percent compared with placebo.

WelChol is currently indicated for lowering LDL cholesterol and was approved by the FDA in 2000. WelChol is highest selling brand drug in the bile acid sequestrants class. WelChol is non-systemic, meaning that the body does not absorb it and it is eliminated without traveling to the liver or kidneys, according to the drugmaker.

WelChol is also approved for use in combination with a statin, and the combination can lower cholesterol levels more effectively than using either therapy alone, according to Daiichi Sankyo. In pivotal studies where WelChol was taken with a statin, the drug provided up to an additional mean 16 percent reduction in LDL cholesterol.