Fixed-Dose Combination Tablet Significantly Reduces Cholesterol, Notes Study

July 31, 2019
Pharmaceutical Technology Editors

Daiichi Sankyo Europe has revealed the results of a Phase III study assessing the efficacy, safety, and tolerability of bempedoic acid/ezetimibe fixed-dose combination (FDC) tablet.

German-based Daiichi Sankyo Europe has revealed the results of a Phase III study assessing the efficacy, safety, and tolerability of bempedoic acid/ezetimibe fixed-dose combination (FDC) tablet, demonstrating a significant reduction in cholesterol.

In a July 31, 2019 press release, the company announced that the study, published in the European Journal of Preventative Cardiology, had met the primary endpoint of lowering LDL-C as well as key secondary endpoints. The FDC tablet, which is administered orally, once a day, was found to significantly reduce LDL-C by 38% (placebo-corrected) and high-sensitivity C-reactive protein (hsCRP) by 35% from baseline. Additionally, the treatment was found to have a favorable safety profile and was well-tolerated when added to maximum-tolerated statin therapy.

“The results of this study show that the bempedoic acid/ezetimibe FDC tablet provided significant additional LDL-C lowering and hsCRP reductions when added to maximally tolerated statin therapy,” said Christie M. Ballantyne, professor of medicine at the Baylor College of Medicine, Houston, Texas and lead study author in the press release. “For patients who are not at their goal levels despite currently accessible therapies, the LDL-C lowering and hsCRP reductions seen with the bempedoic acid/ezetimibe FDC tablet support that this could be a very important treatment option.”

“We are pleased to report the superior LDL-C and hsCRP lowering benefits versus placebo that the FDC of bempedoic acid with ezetimibe brings to patients at high risk of CVD [cardiovascular disease] who do not reach their target for LDL-C despite being on maximally tolerated statin therapy. These results add to the growing body of evidence supporting bempedoic acid and the bempedoic acid/ezetimibe FDC tablet,” added Wolfgang Zierhut, head of Antithrombotic and Cardiovascular Medical Affairs Department at Daiichi Sankyo Europe. “With its liver specific mode of action, bempedoic acid avoids the debilitating muscle-related side-effects that are often associated with statins and could serve as a valuable complementary treatment option to hypercholesterolemia patients who are not reaching their goals with existing treatment options.”

The combination tablet and bempedoic acid are both currently under review for marketing authorization by the European Medicines Agency and by the US Food and Drug Administration.

Source: Daiichi Sankyo Europe