Esperion Announces Bempedoic Acid Recommended as Oral Non-Statin Therapy for LDL-Cholesterol Lowering

Esperion recently announced bempedoic acid (NEXLETOL) is now recommended as an important oral non-statin therapy for LDL-cholesterol (LDL-C) lowering in the management of atherosclerotic cardiovascular disease (ASCVD) by the American College of Cardiology (ACC) task force on expert consensus decision pathways (ECDP). The recommendation, an update to the 2017 ECDP, was released on August 25, 2022, and published online in the Journal of the American College of Cardiology.

“The recommendation of bempedoic acid for LDL-C lowering in individuals at high-risk for ASCVD reflects an important management strategy for providers and the millions of patients who cannot reach their LDL-C goals with a statin alone,” said JoAnne Foody, MD, FACC, FAHA, Chief Medical Officer of Esperion. “LDL-C is causative in development of atherosclerotic CV disease and residual CV risk remains high if LDL-C remains elevated despite statins. While studies show reducing LDL-C levels with lipid-lowering agents lowers incidence of ASCVD events, most patients still do not reach their LDL-C goal. There is urgent need for the use of non-statin lipid-lowering therapies in appropriate patients to reduce LDL-C. The ACC ECDP recommendation underscores the importance of LDL-C lowering via multiple therapeutic options including oral therapies like bempedoic acid and ezetimibe and provides important guidance for the management of patients not served by current statin therapies.”

“These guidelines will be helpful for providers and payers to understand the value of non-statin therapies in helping patients achieve LDL-C goals,” said BJ Swartz, Chief Strategy Officer of Esperion. “They provide clear guidance on how new and existing non-statin adjunctive therapies will contribute to LDL-C goal attainment and have the potential to reduce cardiovascular risk in their patient populations.”

The 2022 ACC Expert Consensus statement seeks to address current gaps in care for LDL-C lowering to reduce ASCVD risk and provides recommendations for clinicians and patients regarding the use of non-statin therapies in high-risk patients who have a minimal response to statins or are statin intolerant. The recommendation of bempedoic acid, the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002, is based on robust Phase 3 clinical trial evidence including evidence from the CLEAR Tranquility (Evaluation of the Efficacy and Safety of Bempedoic Acid [ETC-1002] as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C) and CLEAR Serenity (Evaluation of the Efficacy and Safety of Bempedoic Acid in Patients With Hyperlipidemia and Statin Intolerant) trials, which demonstrated that monotherapy with bempedoic acid 180 mg daily in patients with statin-associated muscle symptoms on no statin therapy reduced LDL-C levels by approximately 24.5% compared with placebo.

In addition to the ACC ECDP, the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) recommend bempedoic acid for treating LDL-C to goal in their Dyslipidemia and Prevention of Cardiovascular Disease Algorithm. The potential ability of bempedoic acid to reduce cardiovascular risk in patients with statin-intolerance is currently being evaluated in a global cardiovascular outcomes trial (CVOT), known as CLEAR Outcomes. The Company anticipates top-line results from the trial in the first quarter of 2023.

The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined. Esperion initiated a global cardiovascular outcomes trial (CVOT) to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin. The CVOT — known as CLEAR Cardiovascular Outcomes Trial — is an event-driven, global, randomized, double-blind, placebo-controlled study that completed enrollment in August 2019 of over 14,000 patients with hypercholesterolemia and high CVD risk at over 1,200 sites in 32 countries.

NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Limitations of Use: The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

Esperion works hard to make our medicines easy to get, easy to take and easy to have. We discover, develop, and commercialize innovative medicines and combinations to lower cholesterol, especially for patients whose needs are not being met by the status quo. Our entrepreneurial team of industry leaders is inclusive, passionate and resourceful. We are singularly focused on managing cholesterol so you can improve your health easily. Esperion commercializes NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) Tablets and is the leader in the development of convenient oral, once-daily non-statin LDL-cholesterol lowering drugs for patients with high levels of bad cholesterol. For more information, visit www.esperion.com.