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Photo: Welchol(TM) (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults with Type 2 Diabetes
Date:1/22/2008

First and only medication approved to reduce both A1C and LDL cholesterol

PARSIPPANY, N.J., Jan. 22 /PRNewswire/ -- Daiichi Sankyo, Inc., announced that the United States Food and Drug Administration (FDA) has approved Welchol(TM) (colesevelam HCl) to improve glycemic control (measured as hemoglobin A1C) in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other anti-diabetic agents. Welchol is now the first and only medication approved to reduce both glucose levels and low density lipoprotein cholesterol levels (LDL-C). The ADA estimates that 20.8 million people in the United States have diabetes with more than 90 percent of these people having type 2 diabetes.(1) Forty percent of patients with type 2 diabetes also have high LDL-cholesterol.(2) Welchol is a new option that addresses both these chronic health conditions and provides physicians with a unique therapeutic approach for treating patients with type 2 diabetes.
(Photo: http://www.newscom.com/cgi-bin/prnh/20080122/NYTU059 )

To view the Multimedia News Release, go to:

http://www.prnewswire.com/mnr/welchol/29889/

Pivotal data presented at the American Diabetes Association's (ADA) 67TH Annual Scientific Sessions in Chicago in June, 2007 demonstrated that Welchol can lower both A1C and LDL-C levels in patients with type 2 diabetes who were uncontrolled on a metformin-based regimen. Patients in the study were randomly assigned to two groups. The addition of Welchol was compared to the addition of placebo in patients on a metformin-based regimen. The addition of Welchol (n=79) to pre-existing metformin monotherapy achieved a significant mean reduction in A1C levels of 0.47 percent relative to placebo (p<0.0024). Further, the total Welchol tr
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SOURCE Daiichi Sankyo, Inc.
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