Daiichi Sankyo WelChol gains Type 2 diabetes indication

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The FDA has approved Daiichi Sankyo’s cholesterol treatment WelChol (colesevelam HCl) for the improvement of glycemic control in adults with Type 2 diabetes mellitus.

The Parsippany, N.J.-based company said the medication is the first medication to be approved for lowering both glucose and LDL cholesterol levels.

The approval is for the drug’s use in combination with metformin, sulfonylureas or insulin, the company said. The labeling states that WelChol has not been tested as a single agent or in combination with a dipeptidyl peptidase-4 inhibitor, Daiichi said.

The product had sales of $217 million during the company’s 2006 fiscal year, which ended March 2007.