First-In-Class Cholesterol-Lowering Treatment NILEMDO® (NEXLETOL® in the U.S.) and Its Combination with Ezetimibe, NUSTENDI® (NEXLIZET® in the U.S.), Approved In Europe To Treat Hypercholesterolemia and Significantly Reduce Cardiovascular Risk
The European Commission has approved label updates for NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid/ezetimibe) to treat hypercholesterolemia and reduce cardiovascular risk. This approval is based on the positive results from the CLEAR Outcomes trial, making these the first and only LDL-C lowering treatments indicated for both primary and secondary prevention of cardiovascular events.
NILEMDO can lower cholesterol by up to 28% when added to statin therapy, while NUSTENDI can reduce LDL-C by 38% in high-risk patients. The Phase 3 CLEAR Outcomes trial involved 13,970 patients and showed a 13% reduction in major adverse cardiovascular events.
Despite existing treatments, up to 80% of patients do not achieve guideline-recommended LDL-C levels, highlighting the need for new options like NILEMDO and NUSTENDI. The approval aims to provide healthcare professionals with better tools to manage cardiovascular risk and reassure patients of effective treatment options.
- Label updates for NILEMDO and NUSTENDI approved by the European Commission.
- NILEMDO reduces LDL-C by up to 28% when added to statin therapy.
- NUSTENDI lowers LDL-C by 38% in high-risk patients.
- Phase 3 CLEAR Outcomes trial showed a 13% reduction in major adverse cardiovascular events.
- Approval provides new options for patients who do not achieve LDL-C levels with existing treatments.
- NILEMDO and NUSTENDI have contraindications for patients with hypersensitivity to bempedoic acid or ezetimibe.
- Potential side effects include hyperuricemia, tendon rupture, upper respiratory tract infection, and elevated liver enzymes.
- Up to 80% of patients do not reach guideline-recommended LDL-C goals despite existing treatments, indicating a significant unmet need.
Insights
The recent approval of NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid / ezetimibe) by the European Commission signifies a major milestone for Daiichi Sankyo and Esperion Therapeutics. This decision is likely to have a positive financial impact on both companies. With cardiovascular disease being a leading cause of death in Europe and the high percentage of patients not meeting LDL-C goals despite current treatments, these new options could capture a significant market share. The
The approval is based on substantial data from the Phase 3 CLEAR Outcomes trial involving 13,970 patients. The data showed a significant reduction in LDL-C levels—up to
From a market perspective, the approval of NILEMDO and NUSTENDI in Europe opens up substantial opportunities. With an estimated one in seven Europeans having high LDL-C levels, the demand for effective treatments is immense. The efficacy shown in the trials offers a competitive edge over existing treatments. Additionally, the fact that up to
– NILEMDO (bempedoic acid), a First-In-Class, Oral Treatment and NUSTENDI (bempedoic Acid / Ezetimibe Fixed-Dose Combination) Receive Label Update Approval from The European Commission as Treatments to Reduce Cardiovascular Risk by Lowering Low-Density Lipoprotein Cholesterol (LDL-C) Levels –
– This Makes Bempedoic Acid the First and Only LDL-C Lowering Treatment Indicated for Primary and Secondary Prevention of Cardiovascular Events –
– Up To
ANN ARBOR, Mich. and MUNICH, Germany, May 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today that the European Commission (EC) has approved the label update of both NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. The EC’s decisions to update the labels of bempedoic acid and bempedoic acid / ezetimibe FDC are based on the positive CLEAR Outcomes trial results and makes them the first and only LDL-C lowering treatments indicated for primary and secondary prevention of cardiovascular events.
The EC decisions follow the previous CHMP opinions received in March this year, and approved bempedoic acid and its fixed-dose combination (bempedoic acid / ezetimibe) for use in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors.
In Europe, around one in seven people have high LDL-C levels, and cardiovascular disease is the leading cause of death, responsible for more than 10,000 lives lost every day. However, up to
Bempedoic acid is a first-in-class oral treatment which lowers cholesterol, and which can be combined with other treatments to help lower cholesterol even further. Bempedoic acid provided additional cholesterol lowering of up to
“Today's announcement marks a pivotal moment in our ongoing efforts to reduce cardiovascular risk. With the new indication, which covers both primary and secondary prevention, we can support healthcare professionals to better meet the treatment needs in their daily practice. At the same time, we’re confident it will reassure patients that their medication truly addresses their CV risk. This reaffirms our commitment to be a trusted ally in improving cardiovascular care throughout Europe,” said Oliver Appelhans, Head of Europe Specialty Division, Daiichi Sankyo Europe GmbH.
“We are delighted with the European Commission’s approval, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said Sheldon Koenig, President and CEO, Esperion. “This further supports our efforts towards delivering innovative treatment options to manage cardiovascular risk for patients with elevated LDL-C.”
“Today’s positive label update reaffirms the efficacy of both these treatments for reducing LDL-C levels and ultimately reducing patients’ risk of serious cardiovascular events,” said Professor Alberico Catapano, University of Milan, Italy. “The announcement will provide doctors across Europe with further confidence in prescribing bempedoic acid, alone or in combination with ezetimibe, for managing the needs of their patients.”
EC approval is based on results of the Phase 3 CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes trial. The trial randomized a total of 13,970 patients aged 18–85 years old and was conducted at 1,250 sites in 32 countries, including 485 sites across Europe. Results from the Phase 3 CLEAR Outcomes trial demonstrated:
- a
13% reduction in the relative risk of major adverse cardiovascular events defined as a four-component composite of death from cardiovascular (CV) causes, non-fatal myocardial infarction, non-fatal stroke or coronary revascularization (MACE-4). - Results of the key secondary endpoints and subgroup analyses have also been published.
INDICATION
NEXLIZET and NEXLETOL are indicated:
- The bempedoic acid component of NEXLIZET and NEXLETOL is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
- established cardiovascular disease (CVD), or
- at high risk for a CVD event but without established CVD.
- As an adjunct to diet:
- NEXLIZET, alone or in combination with other LDL-C lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
- NEXLETOL, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.
Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.
The most common adverse reactions in the primary hyperlipidemia trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in ≥
Adverse reactions reported in ≥
In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence ≥
The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of ≥
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL.
Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
Please see full Prescribing Information for NEXLIZET and NEXLETOL.
Esperion Therapeutics
At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on X at twitter.com/EsperionInc.
CLEAR Cardiovascular Outcomes Trial
CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet. The CLEAR Program seeks to generate important clinical evidence on the safety and efficacy of bempedoic acid, a first in a class ATP citrate lyase inhibitor contained in NEXLETOL and NEXLIZET and its potential role in addressing additional critical unmet medical needs. More than 60,000 people will have participated in the program by the time of its completion. The CLEAR Program includes 5 label-enabling Phase III studies as well as other key Phase IV studies with the potential to reach more than 70 million people with or at risk for CVD based on elevated LDL-C.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
| Media Contacts: | |||
| For Esperion: | For Daiichi Sankyo Europe: | ||
| Investors: | Investor Relations Contact (Japan): | ||
| investorrelations@esperion.com | DaiichiSankyoIR@daiichisankyo.co.jp | ||
| Media: | Dr. Wolfgang Schiessl (Europe) | ||
| Tiffany Aldrich | wolfgang.schiessl@daiichi-sankyo.eu | ||
| corporateteam@esperion.com | +49 151 1714 7317 | ||
| (616) 443-8438 | |||
| Sean Wood (Global / US) | |||
| swood@webershandwick.com | |||
| +1 (212) 445-8310 | |||
FAQ
What is the significance of the European Commission's label update for NILEMDO and NUSTENDI?
How effective is NILEMDO in lowering cholesterol?
What are the results of the CLEAR Outcomes trial for NILEMDO and NUSTENDI?
What are the potential side effects of NILEMDO and NUSTENDI?
What percentage of patients do not reach guideline-recommended LDL-C goals despite existing treatments?
