Pooled Analyses of Bempedoic Acid Phase 3 LDL-C Lowering Clinical Trial Programme to be Presented at the American Heart Association 2019 Scientific Sessions
Bempedoic acid is an oral, once-daily ATP citrate lyase (ACL) inhibitor that reduces cholesterol synthesis in the liver and is currently undergoing regulatory review Bempedoic acid lowered LDL-Cholesterol (LDL-C) in a manner complimentary to other lipid-lowering therapies, including statins, in Phase 3 clinical trials1 Phase 3 clinical trials of bempedoic acid are included in the pooled analyses of efficacy and glycaemic parameters measured in the clinical trial programme
MUNICH, Germany, (November 7, 2019) – Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced that pooled analyses of data from four completed Phase 3 clinical trials of bempedoic acid will be presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia on Sunday 17th November, 2019. Bempedoic acid and its fixed dose combination (FDC) tablet with ezetimibe are currently undergoing regulatory review for marketing authorisation by the European Medicines Agency (EMA) and by the United States Food and Drug Administration (FDA).
Bempedoic acid is being developed as a cost-effective, convenient, once-daily, oral add on treatment for people with hypercholesterolaemia who are unable to reach LDL-C goals after optimised oral lipid lowering therapies and remain at high risk of a cardiovascular event such as heart attack or stroke.
The global, pivotal, Phase 3 clinical development programme reported positive cumulative results in October 2018. The programme evaluated the safety, tolerability and LDL-C-lowering efficacy of bempedoic acid and the bempedoic acid / ezetimibe FDC tablets. The programme enrolled people with hypercholesterolaemia with, or at high risk of, atherosclerotic cardiovascular disease (ASCVD), and who had elevated LDL-C despite maximally-tolerated statins and ezetimibe. Approximately 4,000 patients were enrolled across five clinical trials, four for bempedoic acid and one for the bempedoic acid / ezetimibe FDC tablet.
Details on the oral presentation are as follows: Title: Bempedoic Acid and Glycemic Control: A Pooled Analysis of 4 Phase 3 Clinical Trials Author: Lawrence A Leiter, MD, FRCPC, FACP, FACE, FAHA
Date and Time: Sunday 17th November, 2019 at 11:00 ET (17:00 CET) Location: Science and Technology Hall A, Booth 605, Level 2, Pennsylvania Convention Center, Philadelphia, PA
Details on the poster presentation are as follows: Title: Efficacy of Bempedoic Acid: A Pooled Analysis of 4 Pivotal Phase 3 Clinical Trials Author: Maciej Banach, MD, PhD, FAHA, FESC, FNLA, FASA, FRSPH Date and Time: Sunday 17th November, 2019 at 15:00 ET (21:00 CET) Location: Zone 3, Science and Technology Hall, Pennsylvania Convention Center, Philadelphia, PA
- Daiichi Sankyo
- Daiichi Sankyo