Daiichi Sankyo Seeks FDA Approval Of WelChol With Zetia
This article was originally published in The Pink Sheet Daily
Executive Summary
Japanese firm files data with FDA showing efficacy of WelChol with ezetimibe in reducing LDL cholesterol.
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Daiichi Sankyo is seeking to update labeling for the cholesterol medication WelChol (colesevelam) to include its use in combination with Schering-Plough/Merck's Zetia (ezetimibe). The Japanese firm's U.S. subsidiary announced the sNDA submission March 28. WelChol, a bile acid sequestrant, is currently approved for the reduction of LDL cholesterol alone or in combination with a statin. A study published in Current Medical Research and Opinion in November demonstrated that treatment of primary hypercholesterolemia patients with WelChol in combination with Zetia reduced LDL-C by an average of 32 percent, representing additional LDL-C lowering of 11 percentage over treatment with ezetimibe monotherapy. In January, Daiichi Sankyo filed an sNDA seeking an expanded indication for WelChol to improve glycemic control in patients with type 2 diabetes. If approved for the indication, the drug would be the first LDL-lowering medication also indicated for improving glycemic control (1 (Also see "Daiichi Sankyo Submits WelChol sNDA For Diabetes Indication" - Pink Sheet, 2 Jan, 2007.)). The Japanese pharma has also announced plans to more than double its U.S. sales force by 2010 in an effort to further expand outside of its home market (2 (Also see "Daiichi Sankyo Eyes U.S. Expansion With Major Sales Force Boost" - Pink Sheet, 14 Feb, 2007.)). - Jessica Merrill ([email protected]) [Editor's note: Additional coverage of Asia is provided at 3 Pharm Asia News , F-D-C Reports' new free site for Asian biotech and pharmaceutical news.] |