NEXLETOL (bempedoic acid) Tablets Highlighted in EAS 2020 Presentation of Analysis Demonstrating Significant Cholesterol Lowering in People with Familial Hypercholesterolemia

- NEXLETOL exhibited a 22% mean reduction in LDL-C levels in patients with Heterozygous Familial Hypercholesterolemia at week-12 -

ANN ARBOR, Mich., Oct. 07, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced results of pooled data from two of the company’s Phase 3 trials were presented at the virtual 88^th Annual Congress of the European Atherosclerosis Society (EAS 2020). Both trials demonstrated significant lowering of cholesterol by NEXLETOL (bempedoic acid) Tablets in people with the most common form of inherited high cholesterol.^1,2 The data from this pooled analysis of over 3,000 patients with Atherosclerotic Cardiovascular Disease (ASCVD) and/or Heterozygous Familial Hypercholesterolemia (HeFH) were presented by Professor P. Barton Duell, Professor of Medicine, Oregon Health & Science University and member of Esperion’s Phase 3 Steering Committee.

During the EAS presentation, it was highlighted that NEXLETOL significantly reduced low-density lipoprotein cholesterol (LDL-C) by a mean of 22% compared to placebo in people with HeFH taking maximally tolerated statins with or without other lipid-lowering therapies (LLTs). Mean LDL-C reductions from baseline to week 12 were also significantly greater with NEXLETOL vs placebo for patients without HeFH (placebo-corrected difference: –18%). Consistent with previous clinical studies, NEXLETOL was generally well tolerated in people with HeFH, with no new safety signals seen.ⁱ HeFH is a common condition affecting over 30 million people worldwide who are at increased risk of a cardiovascular event such as a heart attack.³   Additionally, it was shown that many patients with HeFH do not achieve adequate LDL-C lowering despite multidrug therapy, demonstrating a great need for efficacious non-statin LDL-C-lowering medications.

Approved earlier this year by the U.S. Food and Drug Administration (FDA) and launched at the height of the COVID-19 pandemic, NEXLETOL is the first oral, once-daily, non-statin LDL-C lowering medicine available to indicated patients in nearly 20 years. The approval of NEXLETOL was supported by a global pivotal Phase 3 LDL-C lowering program conducted in more than 3,000 patients with ASCVD and/or HeFH. In these studies, NEXLETOL provided an average of 18% placebo corrected LDL-C lowering when used with moderate or high intensity statins. The most common (incidence ≥ 2% and greater than placebo) adverse reactions were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia and elevated liver enzymes. NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or established ASCVD who require additional lowering of LDL-C. The effect of NEXLETOL on cardiovascular morbidity and mortality has not yet been determined. Please see important safety information below.