Daiichi Sankyo’s Nilemdo “significantly” reduces cholesterol levels at ESC 2020

pharmafile | September 1, 2020 | News story | Manufacturing and Production, Research and Development Daiichi Sankyo, Nilemdo, pharma 

Daiichi Sankyo has unveiled promising new benefit for Nilemdo (bempedoic acid) at the ESC Congress 2020 over the weekend for the management of low-density lipoprotein cholesterol (LDL-C) when added to other standards of care.

The drug is currently approved in Europe for the reduction of LDL-C in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia; around 80% of those with these conditions struggle to hit recommended levels of LDL-C even after receiving treatment with statins or other other lipid-lowering therapies (LLTs).

When used in addition to statins and LLTs, data presented at the digital event indicated that Nilemdo “significantly” reduced LDL-C in treated patients compared to placebo 12 weeks following initial dose, and these benefits were maintained for the full 52 weeks of the study.

Furthermore, 1,462 patients who completed the 52 weeks of treatment continued to be evaluated for a further 78 weeks, with some participants having received Nilemdo for a total of 130 weeks by the end of this second study.

In this extension trial, 970 participants received Nilemdo and 492 received placebo. Data from this study were consistent with those seen in its precursor, lowering LDL-C levels by 14.4% compared to placebo on top of maximally tolerated statin therapy and other LLTs throughout the 78 weeks.

Professor Kausik Ray, Professor of Public Heath, Director of the Imperial Centre for CVD Prevention and Deputy Director of Imperial Clinical Trials Unit and Head of Commercial Trials Imperial College London, commented on the findings: “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. 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.”

Matt Fellows

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