Daiichi Sankyo, Inc. has filed a supplemental New Drug Application (sNDA) to the USFDA for WelChol® for the improvement of glycemic control in patients with type 2 diabetes mellitus.
Once approved, WelChol® will become the first LDL cholesterol lowering medication also indicated for improving glycemic control. According to Ronald B. Goldberg, MD, Professor of Medicine, the Division of Diabetes and Metabolism and Associate Director, Diabetes Research Institute at the University of Miami Miller School of Medicine:
"Every physician who treats diabetes is looking to lower A1C as effectively as possible, resulting in a constant lookout for improved combinations of therapy. The same can be said for LDL-cholesterol as well. As a result, a compound that can help lower both of these important cardiovascular risk factors, A1C and LDL-cholesterol, can be of great benefit for manypatients."
Approved by the USFDA for marketing in May 2000, WelChol is indicated for LDL-C lowering and is the top-selling branded drug in the bile acid sequestrants (BAS) class.
Different from most cholesterol-lowering drugs on the market, WelChol is non-systemic: the body does not absorb it and it is eliminated without traveling to the liver or kidneys and therefore is not expected to have drug-drug interactions via the cytochrome P-450 pathway.
Find more details from the press release.
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