Welcholâ„¢ (colesevelam HCl), FDA-Approved for Glycemic Control in Type 2 Diabetes

Filed in archive Developments , News , Treatment on January 20, 2008

Daiichi Sankyo, Inc.'s Welcholâ„¢ (colesevelam HCl) has been approved by the US FDA for the improvement of 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.




The said approval made Welcholâ„¢ the first and only medication approved to reduce both glucose levels and low density lipoprotein cholesterol levels (LDL-C).

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 treatment group, when treated with either metformin monotherapy or metformin-combination therapy, achieved significantly greater reductions in A1C levels compared to placebo (mean reduction of 0.54%, p<0.001). The study further demonstrated that the total Welchol treatment group achieved significantly lower LDL-C levels compared to the placebo group (mean reduction of 15.9%, p<0.001).

Previously, Welcholâ„¢ is also indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor.

Also, Welcholâ„¢ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

However, Welcholâ„¢ should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.

Find more details from PRNewswire.