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news.Daiichi Sankyo has filed with the FDA a label change request for its drug WelChol to include new data demonstrating its effectiveness when combined with ezetimibe, a cholesterol absorption inhibitor.
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WelChol is currently indicated for the reduction of LDL-C either alone or in combination with commonly prescribed statins such as Lipitor, Zocor, Pravachol and Mevacor.
A study recently showed that taking WelChol in combination with ezetimibe reduced LDL-C by a mean 32% which reduced mean LDL-C levels by an additional 11% over ezetimibe monotherapy in patients with primary hypercholesterolemia.
“This data demonstrates the value of combining WelChol plus ezetimibe,” said Harold Bays, Louisville Metabolic and Atherosclerosis Research Center. “This combination helps achieve even lower LDL-C levels, which is important since for every percentage point of reduction in LDL-C, there is a corresponding reduction in risk of developing coronary heart disease.”
However, the effects of WelChol alone or in combination with a statin, fenofibrate, or ezetimibe on cardiovascular morbidity and mortality have not been determined, the company said.