Daiichi Sankyo Announces EU Approval of Novel Cholesterol-Lowering Therapies Nilemdo and Nustendi for Adults with Primary Hypercholesterolemia or Mixed Dyslipidemia
Daiichi-Sankyo
Pharmaceutical R&D Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
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Daiichi Sankyo recently announced that the European Commission (EC) has approved the new cholesterol-lowering drugs Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) for adult patients with primary hypercholesterolemia or mixed dyslipidemia.
In the United States, these two drugs were approved in February this year under the brand names Nexletol (Nilemdo) and Nexlizet (Nustendi), respectively. Their indications are as adjunctive therapy to diet and maximally tolerated statin treatment for adult patients with heterozygous familial hypercholesterolemia, as well as for adult patients with atherosclerotic cardiovascular disease who require further reduction of LDL-C levels.
Notably, Nilemdo is the first oral, once-daily, non-statin LDL-C-lowering drug approved in nearly 20 years. Nustendi is the first approved non-statin combination drug for lowering LDL-C. Both drugs were developed by Esperion Therapeutics, and Daiichi Sankyo obtained the commercialization rights in Europe in January 2019.
The active pharmaceutical ingredient of Nilemdo is bempedoic acid, a first-in-class ATP citrate lyase (ACL) inhibitor that lowers LDL-C by inhibiting hepatic cholesterol synthesis. The active pharmaceutical ingredients of Nustendi are bempedoic acid and ezetimibe, which lower LDL-C through complementary mechanisms by inhibiting hepatic cholesterol synthesis and intestinal cholesterol absorption.
The approval of the two drugs was based on data from the CLEAR trial program. Conducted in more than 4,000 patients at high and very high cardiovascular risk, the study demonstrated that: (1) when administered in combination with maximally tolerated statin therapy, Nilemdo significantly reduced LDL-C levels by 18% compared with placebo; in statin-intolerant patients, Nilemdo significantly reduced LDL-C levels by 28% compared with placebo. (2) when administered in combination with maximally tolerated statin therapy, Nustendi reduced LDL-C levels by 38% compared with placebo.
A pooled safety analysis involving more than 3,600 patients confirmed that bempedoic acid is well tolerated, with an overall incidence of adverse events similar to that of placebo. Due to its novel and unique mechanism of action, bempedoic acid is not activated in skeletal muscle, thereby avoiding the occurrence of muscle-related adverse reactions.
Cardiovascular disease is one of the leading causes of death, claiming more than 4 million lives annually across Europe. Elevated levels of low-density lipoprotein cholesterol (LDL-C) are a major contributor to myocardial infarction, stroke, and other potentially fatal events. The European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines recommend aggressive LDL-C lowering to reduce cardiovascular risk, particularly in patients with uncontrolled lipid levels. However, up to 80% of patients fail to achieve the recommended LDL-C treatment targets, necessitating additional therapeutic options.
The approval and market launch of Nilemdo and Nustendi in the European Union will provide an important new treatment option for adult patients with primary hypercholesterolemia or mixed dyslipidemia in the region. These agents can be used in combination with other lipid-lowering therapies to further reduce LDL-C levels, thereby helping to lower the risk of cardiovascular events such as heart disease and stroke in this population.
Reference source: New first-in-class cholesterol-lowering treatment NILEMDO® and its combination with ezetimibe, NUSTENDI®, approved in Europe
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.