Tuesday, June 18, 2024

Hypercholesterolemia Treatments Approved in Europe

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The European Commission (EC) has approved the label updates for NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid/ezetimibe fixed-dose combination), marking a milestone in managing hypercholesterolemia and preventing cardiovascular events. These first-in-class treatments significantly lower low-density lipoprotein cholesterol (LDL-C) levels, reducing cardiovascular risk. This approval represents a significant advancement in the treatment of hypercholesterolemia.

EC Approves New Hypercholesterolemia Treatments

The decision to update the labels of these innovative treatments is based on the positive results from the CLEAR Outcomes trial, which demonstrated their efficacy in reducing LDL-C levels and subsequently lowering the risk of major adverse cardiovascular events. This trial involved a diverse population of patients at high risk for cardiovascular disease, providing robust evidence for the benefits of bempedoic acid and its combination with ezetimibe.

Hypercholesterolemia is a prevalent condition, affecting millions of people globally.

Despite the availability of statins and other lipid-lowering therapies, a significant proportion of patients do not achieve their target LDL-C levels, leaving them at an increased risk of heart attacks, strokes, and other cardiovascular complications. NILEMDO® and NUSTENDI® offer a new therapeutic option for these patients, especially those who are intolerant to statins or require additional LDL-C lowering.

Bempedoic acid works by inhibiting ATP citrate lyase, an enzyme involved in cholesterol synthesis, providing an additional mechanism to lower LDL-C levels. The fixed-dose combination with ezetimibe, which inhibits cholesterol absorption in the intestine, offers a synergistic approach to cholesterol management, enhancing the overall lipid-lowering effect.

The approval of these treatments in Europe also highlights the importance of addressing unmet medical needs in cardiovascular health. With cardiovascular disease remaining the leading cause of death worldwide, the availability of effective and well-tolerated treatments is crucial. NILEMDO® and NUSTENDI® provide healthcare professionals with new tools to help patients achieve their LDL-C goals and reduce their cardiovascular risk.

European Approval Advances Hypercholesterolemia Treatment

This approval is a significant achievement for Daiichi Sankyo and Esperion Therapeutics, the companies behind these innovative treatments. It underscores their commitment to advancing cardiovascular health through the development of novel therapies. The successful collaboration between these companies and regulatory authorities has paved the way for improved patient outcomes and a brighter future for those affected by hypercholesterolemia and cardiovascular disease.

NILEMDO and NUSTENDI are now the first and only LDL-C lowering treatments indicated for both primary and secondary prevention of cardiovascular events. Despite receiving treatments such as statins, up to 80% of patients do not reach guideline-recommended LDL-C goals. This places them at increased risk of heart attack or stroke, necessitating additional treatment options like bempedoic acid.

Bempedoic acid is a groundbreaking oral treatment that lowers cholesterol and can be combined with other therapies for enhanced effect. In clinical trials, bempedoic acid provided an additional 28% reduction in LDL-C levels on top of statin therapy. The combination of bempedoic acid and ezetimibe in NUSTENDI further reduced LDL-C by 38% compared to placebo in high-risk patients on maximum-tolerated statin therapy.

The Phase 3 CLEAR Outcomes trial formed the basis for the EC’s approval. This extensive trial involved 13,970 patients aged 18-85 across 1,250 sites in 32 countries, including 485 in Europe. The trial demonstrated a 13% reduction in the relative risk of major adverse cardiovascular events, including death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization.

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Industry leaders and healthcare professionals have expressed strong support for the approval. Oliver Appelhans, Head of Europe Specialty Division at Daiichi Sankyo Europe GmbH, highlighted the importance of this new indication in improving cardiovascular care. Sheldon Koenig, President and CEO of Esperion, emphasized the significant cardiovascular risk reduction benefits brought by the bempedoic acid global franchise.

Both NILEMDO and NUSTENDI have been rigorously tested for safety and efficacy. Common adverse reactions include upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, and abdominal discomfort. Physicians are advised to monitor for signs of hyperuricemia and tendon rupture, particularly in patients with predisposing factors.

The approval reaffirms the efficacy of these treatments for reducing LDL-C levels and lowering the risk of serious cardiovascular events. Professor Alberico Catapano from the University of Milan stated that this approval will provide doctors across Europe with greater confidence in prescribing bempedoic acid, either alone or in combination with ezetimibe, for managing patients’ needs.

The European Commission’s approval of NILEMDO and NUSTENDI represents a pivotal development in cardiovascular care. These treatments offer a new, effective option for patients struggling to achieve LDL-C goals with existing therapies. As cardiovascular disease remains the leading cause of death in Europe, this approval is a significant step towards better health outcomes.



Resource: ESPERION, May 22, 2024

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