NILEMDO®▼(bempedoic acid) delivers cholesterol lowering in addition to statin therapy which is maintained during 2.5 years of treatment

• NILEMDO^®▼ (bempedoic acid) is a new, first-in-class, oral, low-density lipoprotein cholesterol (LDL-C) lowering treatment that significantly reduces LDL-C on top of statins and other lipid-lowering therapies[i]
• Bempedoic acid acts on the well-known cholesterol synthesis pathway, upstream of the statin target in the liver1
• Due to its novel mechanism of action, bempedoic acid is not activated in skeletal muscle which decreases the potential for muscle-related side effects1^,[ii]
• The 78-week open-label extension of the 52-week CLEAR Harmony trial was presented at the European Society of Cardiology’s Congress 2020 showing that bempedoic acid is well tolerated and significantly reduces LDL-C over a period of 2.5 years[iii]

MUNICH, Germany, (August 28, 2020) – Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced that NILEMDO^®▼ (bempedoic acid) has demonstrated consistent tolerability and sustained efficacy over 2.5 years, in results presented at the European Society of Cardiology’s (ESC) Congress 2020.3  Bempedoic acid is approved in Europe to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hypercholesterolaemia or mixed dyslipidaemia.¹ Up to 80% of patients do not reach guideline-recommended LDL-C goals despite receiving treatments such as statins and other lipid-lowering therapies (LLTs), and are at increased risk of a heart attack or stroke.[iv]^,[v],[vi]

The data presented at ESC Congress 2020 comes from an open-label extension of the CLEAR Harmony trial, which originally showed that bempedoic acid is generally well tolerated and significantly reduces LDL-C compared to placebo at 12 weeks, on top of statins and other oral LLTs. This was maintained over the 52 weeks of the trial.[vii] People who completed CLEAR Harmony had the option to be enrolled into the open-label extension  in which all participants received bempedoic acid for an additional 78 weeks, meaning some patients received bempedoic acid for 130 weeks in total. Of the 1462 patients who enrolled in the open-label extension study, 970 received bempedoic acid 180mg and 492 received placebo.³

Findings from the extension study showed that bempedoic acid significantly lowered LDL-C by 14.4% on top of maximally tolerated statin therapy and other LLTs throughout 78 weeks of treatment, which are consistent with results seen in the original study.3

“Many people have a long-term need for treatments that are well tolerated and will help them keep their LDL-C levels low in order to reduce their risk of cardiovascular events, such as a heart attack or stroke. Therefore, it is important to know how people respond to treatment over longer-term time periods,” said Professor Kausik Ray, Professor of Public Heath, Director of the Imperial Centre for CVD Prevention, Deputy Director of Imperial Clinical Trials Unit and Head of Commercial Trials Imperial College London and Consultant Cardiologist. “This study can give our colleagues confidence that the LDL-C reductions we see with bempedoic acid are maintained over time, without a significant increase of overall adverse events on top of statins and other LLTs.”

[i] European Medicines Agency. NILEMDO^® Summary of Product Characteristics. March 2020.  

[ii] Pinkosky SL, et al. Liver- specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nature Communications. 2016; 7:13457. DOI:10.1038/ncomms13457.

[iii] Ballantyne CM, et al. Long-term safety and efficacy of bempedoic acid in patients at high risk of atherosclerotic cardiovascular disease: results from the clear harmony open-label extension. Poster presentation at the European Society of Cardiology Congress 2020.

[iv] The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). ESC/EAS guidelines for the management of dyslipidaemia. Eur Heart J. 2020 Jan 1;41(1):111-188. doi:10.1093/eurheartj/ehz455.

[v] Fox KM, et al. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol 2018; 107: 380–388.

[vi] Kotseva K, et al. Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: Results from the European Society of Cardiology ESC-EORP EUROASPIRE V registry. Eur J Prev Cardio. 2019;26(8):824–835.

[vii] Ray KK, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019; 380:1022–32