7 April 2020 - - The European Commission has approved both Nilemdo (bempedoic acid) and Nustendi (bempedoic acid / ezetimibe) for use in adults with primary hypercholesterolaemia or mixed dyslipidaemia in Europe, Japan-based Daiichi Sankyo's Daiichi Sankyo Europe GmbH said.

Bempedoic acid has a unique mechanism of action which is complementary to statins and other lipid-lowering therapies allowing additional LDL-C lowering on top of other LLTs compared to placebo.

Both approvals were supported by data from the CLEAR trial programme conducted in more than 4,000 high- and very high-risk patients.6-10

Nilemdo is a new, first-in-class, affordable, oral treatment which lowers cholesterol, and can be combined with other oral treatments to help lower cholesterol even further.

It provides additional LDL-C lowering of up to 28% on top of other lipid-lowering therapies, compared to placebo by inhibiting ATP Citrate Lyase, an enzyme in the well-known cholesterol synthesis pathway, upstream of the statin target in the liver.

Nustendi is a fixed dose combination tablet of bempedoic acid and ezetimibe which combines two complementary ways of reducing cholesterol in a convenient, once-daily, oral treatment with the potential to support adherence to treatment by reducing pill burden for patients.

Bempedoic acid inhibits cholesterol production in the liver while ezetimibe reduces absorption of dietary cholesterol in the gut.

In a Phase 3 clinical trial Nustendi reduced LDL-C by 38% compared to placebo in high-risk patients already taking maximum-tolerated statin therapy.

A combined safety analysis in more than 3,600 patients confirms that bempedoic acid is well tolerated, and overall adverse event rates were similar to placebo.

Due to its novel mechanism of action, Nilemdo is not activated in skeletal muscle which decreases the potential for muscle-related adverse effects.

Up to 80% of patients do not reach guideline-recommended LDL-C goals despite receiving treatments such as statins, and are at increased risk of a heart attack or stroke.

With a unique mechanism of action, Nilemdo is a new, first-in-class, affordable, oral treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.

Bempedoic acid inhibits ATP citrate lyase, an enzyme which is involved in the production of cholesterol in the liver.