NEXLETOL® (bempedoic acid) Tablets Highlighted at AHA 2020 with Presentations of Analyses Demonstrating Significant Low-Density Lipoprotein Cholesterol (LDL-C) Lowering vs. Placebo in Phase 3 Study Subgroups

Rhea-AI Summary

Esperion announced significant results from pooled analyses of its Phase 3 trials for NEXLETOL (bempedoic acid), presented at AHA 2020. The drug showed a mean LDL-C reduction of 26.5% against placebo in statin-intolerant patients after 12 weeks. In analyses by sex, females experienced a 27.7% lowering, while males saw 22.1%. Generally, bempedoic acid was well tolerated. NEXLETOL, the first oral, once-daily non-statin LDL-C-lowering medication in nearly 20 years, received FDA approval in February 2020.

Positive

• Significant mean LDL-C reduction of 26.5% in statin-intolerant patients.
• Bempedoic acid was well tolerated with comparable TEAEs to placebo.
• Potential market expansion as it addresses a significant population of statin-intolerant patients.

Negative

• The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

- Significant mean reduction of 26.5% in LDL-C with bempedoic acid vs. placebo in pooled analysis of people who cannot tolerate statins¹ -

- Analysis by sex showed bempedoic acid significantly lowered LDL-C at week 12 in males and females* vs. placebo² -

ANN ARBOR, Mich., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced results of pooled data from four of the company’s Phase 3 trials were presented at the virtual American Heart Association Scientific Sessions 2020 (AHA 2020). Both analyses demonstrated significant lowering of low-density lipoprotein cholesterol (LDL-C) by NEXLETOL® (bempedoic acid) Tablets by week 12 in specific subgroups, including people who cannot tolerate statins and females, compared to placebo.     

“Women are half of the population, and nearly 10 million patients in the U.S. with high LDL-C levels are not on statins due to tolerability issues,³ yet these groups have been underrepresented in previous medical research,⁴” said Ashley Hall, Chief Development Officer for Esperion. “Our goal at Esperion is lipid management for everybody, and these analyses show significant LDL-C efficacy and acceptable safety for NEXLETOL in these subgroups.”

In “Efficacy and Safety of Bempedoic Acid in Patients Who Cannot Tolerate Any Dose of a Statin: Pooled Analysis from Phase 3 Clinical Trials,” (Abstract #P2139) data from a subgroup of more than 580 patients not receiving any dose of a statin showed a significant mean reduction of 26.5% (p< 0.001) in LDL-C by week 12 with NEXLETOL vs. placebo. NEXLETOL was generally well tolerated, with treatment-emergent adverse events (TEAEs) comparable across the bempedoic acid and placebo groups.¹

The poster “Efficacy and Safety of Bempedoic Acid by Sex: Pooled Analyses From Phase 3 Trials” (Abstract #P742) showed NEXLETOL significantly lowered LDL-C at week 12 in both sexes compared with placebo for a pooled population of more than 3,600 patients across four studies. LDL-C lowering was numerically greater in females compared with males across both pools of the study: The placebo-corrected mean reduction was 27.7% for females vs. 22.1% for males (interaction p value=0.079) in the statin-intolerant pool, and 21.2% for females vs. 17.4% for males (interaction p value=0.044) in the pool of patients with atherosclerotic cardiovascular disease (ASVCD) and/or heterozygous familial hypercholesterolemia (HeFH) who were receiving background maximally tolerated statin. Bempedoic acid was generally well tolerated by both sexes.²

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.

*Note: Esperion strives to be inclusive in our both research and our language, and we follow the language guidance outlined in “Reporting Sex, Gender, or Both in Clinical Research?” from The Journal of the American Medicine Association (JAMA).

NEXLETOL® (bempedoic acid) Tablet

NEXLETOL is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptors. NEXLETOL is the first oral, once-daily, non-statin LDL-C lowering medicine approved in the U.S. in nearly 20 years for patients with ASCVD or HeFH. NEXLETOL was approved by the FDA in February 2020.

Indication and Limitation of Use

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. The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

Important Safety Information

• Warnings and Precautions:
  • Elevations in serum uric acid have occurred. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. The risk for gout events with NEXLETOL® (bempedoic acid) tablet was higher in patients with a prior history of gout although gout also occurred more frequently than placebo in patients treated with NEXLETOL™ (bempedoic acid) tablet who had no prior gout history.
  • Tendon rupture has occurred. Discontinue NEXLETOL® (bempedoic acid) tablet at the first sign of tendon rupture. Avoid NEXLETOL® (bempedoic acid) tablet in patients who have a history of tendon disorders or tendon rupture.
• Adverse Reactions:
• Drug Interactions:
  • Avoid concomitant use of NEXLETOL with simvastatin greater than 20 mg.
  • Avoid concomitant use of NEXLETOL with pravastatin greater than 40 mg.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Esperion at 833-377-7633 (833 ESPR

FAQ

What were the results of the Phase 3 trials for ESPR?

The trials demonstrated a mean LDL-C reduction of 26.5% with bempedoic acid in statin-intolerant patients after 12 weeks.

What is the significance of NEXLETOL's results regarding sex?

Bempedoic acid significantly lowered LDL-C by 27.7% in females compared to 22.1% in males, indicating potential sex-based efficacy.

When was NEXLETOL approved by the FDA?

NEXLETOL was approved by the FDA in February 2020.

What is the safety profile of NEXLETOL based on the trials?

NEXLETOL showed a favorable safety profile, with treatment-emergent adverse events comparable to placebo.