Esperion鈥檚 Bempedoic Acid Receives Level 1a Recommendation in Updated ESC/EAS Guidelines for Management of Dyslipidaemias
Esperion (NASDAQ: ESPR) announced that bempedoic acid has received a prestigious Level 1a recommendation in the 2025 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) Guidelines for Dyslipidaemias management.
The guidelines specifically recommend bempedoic acid as the only non-statin newly recommended treatment for LDL-C lowering and cardiovascular risk reduction. Key recommendations include using bempedoic acid for patients unable to take statins (Class I, Level A/B) and considering its addition to maximum statin doses with/without ezetimibe for high-risk patients (Class IIa, Level C).
This recognition supports Esperion's strategic development of oral triple combination therapies, aligning with the guidelines' emphasis on earlier, aggressive combination therapy. The company's portfolio includes NEXLETOL (bempedoic acid), NEXLIZET (bempedoic acid and ezetimibe), and upcoming triple combinations with atorvastatin or rosuvastatin.
Esperion (NASDAQ: ESPR) ha annunciato che l'acido bempedoico ha ottenuto una prestigiosa raccomandazione Livello 1a nelle Linee guida 2025 della European Society of Cardiology (ESC) e della European Atherosclerosis Society (EAS) per la gestione delle dislipidemie.
Le linee guida indicano specificamente l'acido bempedoico come l'unico nuovo trattamento non-statina raccomandato per la riduzione del LDL-C e del rischio cardiovascolare. Le raccomandazioni chiave includono l'uso di bempedoico nei pazienti che non possono assumere statine (Classe I, Livello A/B) e la sua eventuale aggiunta alla dose massima di statina con o senza ezetimibe per pazienti ad alto rischio (Classe IIa, Livello C).
Questo riconoscimento supporta la strategia di Esperion nello sviluppo di terapie orali in triplice combinazione, in linea con l'enfasi delle linee guida su un trattamento combinato precoce e intensivo. Il portafoglio aziendale comprende NEXLETOL (acido bempedoico), NEXLIZET (acido bempedoico ed ezetimibe) e prossime combinazioni triple con atorvastatina o rosuvastatina.
Esperion (NASDAQ: ESPR) anunci贸 que el 谩cido bempedoico ha recibido una prestigiosa recomendaci贸n Nivel 1a en las Gu铆as 2025 de la European Society of Cardiology (ESC) y la European Atherosclerosis Society (EAS) para el manejo de las dislipidemias.
Las gu铆as recomiendan espec铆ficamente el 谩cido bempedoico como el 煤nico tratamiento nuevo no estatina recomendado para reducir el LDL-C y el riesgo cardiovascular. Las recomendaciones clave incluyen usar bempedoico en pacientes que no pueden tomar estatinas (Clase I, Nivel A/B) y considerar su adici贸n a la dosis m谩xima de estatina con o sin ezetimiba en pacientes de alto riesgo (Clase IIa, Nivel C).
Este reconocimiento respalda la estrategia de Esperion de desarrollar terapias orales en triple combinaci贸n, alineada con el 茅nfasis de las gu铆as en una terapia combinada m谩s temprana y agresiva. La cartera de la compa帽铆a incluye NEXLETOL (谩cido bempedoico), NEXLIZET (谩cido bempedoico y ezetimiba) y pr贸ximas combinaciones triples con atorvastatina o rosuvastatina.
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歆�旃潃 氩绊帢霃勳澋靷办潉 LDL-C 鞝�頃� 氚� 鞁槇甏� 鞙勴棙 臧愳唽毳� 鞙勴暅 鞙犾澕頃� 鞁犼窚 牍勳姢韮�韹� 甓岅碃 旃橂鞝�搿� 甑泊鞝侅溂搿� 甓岇灔頃╇媹雼�. 欤检殧 甓岅碃靷暛鞚� 鞀ろ儉韹挫潉 氤奠毄頃� 靾� 鞐嗠姅 頇橃瀽鞐愱矊 氩绊帢霃勳澋靷� 靷毄(韥措灅鞀� I, 攴缄卑 靾橃 A/B)瓿� 瓿犾渼項� 頇橃瀽鞐� 雽�頃� 斓滊寑 鞀ろ儉韹� 鞖╇焿鞐� ezetimibe鞚� 鞙犽鞕� 靸侁磤鞐嗢澊 氩绊帢霃勳澋靷办潉 於旉皜頃橂姅 瓴冹潉 瓿犽牑(韥措灅鞀� IIa, 攴缄卑 靾橃 C)頃橂姅 瓴冹瀰雼堧嫟.
鞚� 鞚胳爼鞚� 氤措嫟 臁瓣赴鞚搓碃 臧曤牓頃� 氤戫暕鞖旊矔鞚� 臧曥“頃� 歆�旃臣 氚滊於� 瓴疥惮 3鞝� 氤戩毄 旃橂 臧滊皽鞚� 於旍頃橂姅 Esperion鞚� 鞝勲灥鞚� 歆�鞗愴暕雼堧嫟. 須岇偓 韽姼韽措Μ鞓れ棎電� NEXLETOL(氩绊帢霃勋澋靷�), NEXLIZET(氩绊帢霃勳澋靷� 氚� 鞐愳牅韹半敫�) 氚� 頄ロ泟 鞎勴啝毳措皵鞀ろ儉韹� 霕愲姅 搿滌垬氚旍姢韮�韹搓臣鞚� 3鞝� 氤戩毄 鞝滍拡鞚� 韽暔霅╇媹雼�.
Esperion (NASDAQ: ESPR) a annonc茅 que l'acide bempedo茂que a obtenu une prestigieuse recommandation de niveau 1a dans les recommandations 2025 de la European Society of Cardiology (ESC) et de la European Atherosclerosis Society (EAS) pour la prise en charge des dyslipid茅mies.
Les lignes directrices recommandent sp茅cifiquement l'acide bempedo茂que comme le seul nouveau traitement non statine recommand茅 pour r茅duire le LDL-C et le risque cardiovasculaire. Les recommandations cl茅s incluent l'utilisation de l'acide bempedo茂que chez les patients incapables de prendre des statines (Classe I, Niveau de preuve A/B) et la consid茅ration de son ajout 脿 la dose maximale de statine avec ou sans 茅z茅timibe pour les patients 脿 haut risque (Classe IIa, Niveau C).
Cette reconnaissance soutient la strat茅gie d'Esperion visant 脿 d茅velopper des traitements oraux en triple combinaison, en accord avec l'accent mis par les lignes directrices sur une prise en charge combin茅e plus pr茅coce et plus intensive. Le portefeuille de la soci茅t茅 comprend NEXLETOL (acide bempedo茂que), NEXLIZET (acide bempedo茂que et 茅z茅timibe) et des combinaisons triples 脿 venir avec atorvastatine ou rosuvastatine.
Esperion (NASDAQ: ESPR) gab bekannt, dass Bempedoins盲ure in den Leitlinien 2025 der European Society of Cardiology (ESC) und der European Atherosclerosis Society (EAS) zur Behandlung von Dyslipid盲mien eine renommierte Empfehlung Level 1a erhalten hat.
Die Leitlinien empfehlen Bempedoins盲ure ausdr眉cklich als einzige neu empfohlene nicht-statinhaltige Behandlung zur Senkung von LDL-C und zur Reduktion des kardiovaskul盲ren Risikos. Zentrale Empfehlungen sind der Einsatz von Bempedoins盲ure bei Patienten, die keine Statine einnehmen k枚nnen (Klasse I, Evidenzst盲rke A/B), sowie die Erw盲gung einer Erg盲nzung zur maximalen Statindosis mit/ohne Ezetimib bei Hochrisikopatienten (Klasse IIa, Evidenzst盲rke C).
Diese Anerkennung unterst眉tzt Esperions strategische Entwicklung oraler Dreifach-Kombinationen und steht im Einklang mit dem Leitlinienfokus auf ein fr眉heres, aggressiveres Kombinationsregime. Das Portfolio des Unternehmens umfasst NEXLETOL (叠别尘辫别诲辞颈苍蝉盲耻谤别), NEXLIZET (Bempedoins盲ure und Ezetimib) sowie bevorstehende Dreifachkombinationen mit Atorvastatin oder Rosuvastatin.
- Received highest level (1a) recommendation from prestigious ESC/EAS guidelines
- Only non-statin treatment newly recommended for LDL-C lowering and CV risk reduction
- Strategic alignment with industry shift towards early combination therapy
- Expanded market potential through European partner Daiichi Sankyo
- Development of first oral lipid-lowering triple combination pill in progress
- Safety concerns including risk of hyperuricemia and tendon rupture
- Multiple adverse reactions reported in clinical trials
- Contraindicated during pregnancy and breastfeeding
Insights
ESC/EAS guidelines' strong endorsement of bempedoic acid validates Esperion's product and strengthens its market position in Europe and potentially the US.
The recognition of bempedoic acid in the 2025 European Society of Cardiology/European Atherosclerosis Society Guidelines represents a significant clinical validation for Esperion's flagship product. This is particularly noteworthy as bempedoic acid is the only non-statin newly recommended for LDL-C lowering and cardiovascular risk reduction in these updated guidelines.
The recommendation comes with substantial clinical weight - receiving a Class I, Level A recommendation for patients unable to take statins, and a Class I, Level B recommendation specifically for bempedoic acid in statin-intolerant patients. This positions the drug favorably in the treatment algorithm for hyperlipidemia.
From a commercial perspective, this endorsement provides Esperion's European partner, Daiichi Sankyo Europe, with powerful clinical support to accelerate market access and adoption across European territories. European guideline recognition typically influences prescribing patterns significantly, as physicians tend to closely follow these evidence-based recommendations.
The potential impact extends beyond Europe, as these guidelines may inform upcoming US cholesterol treatment guidelines. This regulatory momentum aligns with Esperion's strategic pipeline development, particularly their triple combination therapies that combine bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin - positioning them to capitalize on the guidelines' emphasis on earlier, aggressive combination therapy.
This development strengthens Esperion's competitive position against other non-statin therapies and potentially expands their addressable market, particularly among the clinically significant population of patients who cannot tolerate statins or require additional LDL-C lowering beyond statin therapy.
Bempedoic acid's Level 1a recommendation validates its clinical efficacy and positions it as a critical option for statin-intolerant patients.
The updated ESC/EAS guidelines represent a significant clinical endorsement for bempedoic acid, recognizing its demonstrated efficacy in both LDL-C reduction and cardiovascular risk reduction. The Class I, Level A recommendation - the highest level of evidence-based endorsement - positions this agent as a validated therapeutic option in the lipid management armamentarium.
Clinically, this recognition addresses a critical treatment gap for the estimated 10-15% of patients who experience statin-associated muscle symptoms or other statin intolerances. For these patients, bempedoic acid now stands as a guideline-supported alternative with proven cardiovascular outcomes benefits.
The guidelines also recognize bempedoic acid's role in combination therapy (Class IIa, Level C recommendation), acknowledging the frequent need for multiple mechanisms to achieve target LDL-C levels in high-risk patients. This aligns with the growing clinical understanding that earlier, more aggressive lipid-lowering therapy produces better long-term cardiovascular outcomes.
From a mechanism perspective, bempedoic acid's unique action as an ATP-citrate lyase (ACL) inhibitor provides complementary LDL-C lowering to both statins and ezetimibe through a distinct upstream pathway in cholesterol synthesis. This mechanistic differentiation supports its use in combination approaches.
Esperion's development of oral triple combination therapies responds directly to the clinical need for simplified regimens that improve adherence - a persistent challenge in chronic preventive therapy. Single-pill combinations have consistently demonstrated improved medication adherence compared to multiple separate pills, potentially translating to better real-world outcomes in cardiovascular risk reduction.
鈥撀燘empedoic Acid Receives Strongest Endorsement from ESC/EAS Guidelines Based on Compelling and Practice-Changing Evidence 鈥�
鈥� Guideline Recognition of 鈥楽trike Early and Strike Strong鈥� Approach with Early Combination Lipid-Lowering Therapy Affirms Continued Development of Company鈥檚 Oral Triple Combination Therapies in U.S. 鈥�
ANN ARBOR, Mich., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today welcomed the inclusion of bempedoic acid as the only non-statin newly recommended for LDL-C lowering and cardiovascular risk reduction in the 2025 Focused Update of the 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemias.
鈥淩ecognition from Europe鈥檚 premier cardiovascular medical association further validates the clinical benefit of bempedoic acid in cardiovascular risk reduction,鈥� said Sheldon Koenig, President and CEO of Esperion. 鈥淭his recommendation marks a significant milestone for our European partner, Daiichi Sankyo Europe, as they continue to expand access across Europe, and is equally meaningful for our efforts in the U.S., where we anticipate the European guidelines will inform upcoming U.S. cholesterol treatment guidelines.鈥�
Key ESC/EAS Recommendations for LDL-C Lowering
- Non-statin therapies with proven cardiovascular benefit (including bempedoic acid), taken alone or in combination, are recommended for patients who are unable to take statin therapy to lower LDL-C levels and reduce the risk of CV events. The choice should be based on the magnitude of additional LDL-C lowering needed. Class I, Level A
- Bempedoic acid is recommended in patients who are unable to take statin therapy to achieve the LDL-C goal. Class I, Level B
- The addition of bempedoic acid to the maximally tolerated dose of statin with or without ezetimibe should be considered in patients at high or very high risk in order to achieve the LDL-C goal. Class IIa, Level C
The guidelines, entitled 鈥�2025 Focused Update of the 2019 ESC/EAS Guidelines for the Management of Dyslipidaemias,鈥� were published in聽European Heart Journal聽by ESC and EAS. The full guidelines are available via open access
European updated guidelines emphasize the importance of earlier, aggressive combination therapy, an industry shift which Esperion foresaw and strategically positioned itself to lead by developing the first oral lipid lowering triple combination pill in the US. These polypills are designed to potentially provide unprecedented LDL-C lowering, improved adherence with a single pill, and an earlier introduction into the treatment cycle. These advanced therapies will provide physicians and patients with a flexible suite of oral options to improve outcomes and long-term success, including monotherapy (NEXLETOL庐 (bempedoic acid) tablets), dual therapy (NEXLIZET庐 (bempedoic acid and ezetimibe) tablets), and the upcoming triple combination of bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin.
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 鈮�
Adverse reactions reported in 鈮�
In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence 鈮�
The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of 鈮�
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 and .
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms.
Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit and follow Esperion on and .
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, expected profitability, 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 profitability, and other statements containing the words 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥減lan,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥渟uggest,鈥� 鈥渢arget,鈥� 鈥減otential,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� 鈥渃ould,鈥� 鈥渟hould,鈥� 鈥渃ontinue,鈥� 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鈥檚 actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion鈥檚 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鈥檚 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.
Esperion Contact Information:
Investors:
Alina Venezia
(734) 887-3903
Media:
Tiffany Aldrich
(616) 443-8438
FAQ
What is the new ESC/EAS guideline recommendation for Esperion's bempedoic acid in 2025?
How does the ESC/EAS recommendation affect ESPR's market position?
What are the main products in Esperion's (ESPR) lipid-lowering portfolio?
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How does ESPR's treatment strategy align with new ESC/EAS guidelines?
