FDA Expands Label for Bempedoic Acid to Reduce Cardiovascular Risk, With or Without Statins

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Bempedoic acid (Nexletol; Esperion) and bempedoic acid and ezetimibe (Nexlizet; Esperion) are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.

The FDA has approved a broad new label expansion for bempedoic acid (Nexletol; Esperion Therapeutics) and bempedoic acid and ezetimibe (Nexlizet; Esperion) to reduce cardiovascular risk and expanded the low-density lipoprotein-C (LDL-C) lowering in both primary and secondary prevention patients, according to the press release. Furthermore, the approval also includes an indication for primary hyperlipidemia, alone or in combination with statins.1

a graphic representation of a human heart with red and blue arteries branching out from it Generative AI | Image Credit: catalin - stock.adobe.com

Image Credit: catalin - stock.adobe.com

The 2 drugs are the only LDL-C lowering non-statin drugs indicated for primary prevention patients, according to the press release.1

“These approvals expand the accessibility of our highly effective drugs to primary prevention patients, or to those who are at high risk of having a cardiovascular event, but who have not yet had one. These approvals also eliminate the statin use requirement, allowing patients to take [bempedoic acid] or [bempedoic acid and ezetimibe] either with or without a statin, which significantly reduces previously existing prescribing limitations. We are confident these approvals position [bempedoic acid] and [bempedoic acid and ezetimibe] as the non-statins of first choice within the cardiovascular risk reduction treatment paradigm,” Sheldon Koenig, president and CEO of Esperion, said in the press release.1

The approval by the FDA for the new indications were based on data from the CLEAR Outcomes (NCT02993406) trial, which assessed the effect of bempedoic acid on cardiovascular outcomes in 14,000 individuals with or at high risk of cardiovascular disease. Furthermore, the patients were followed for a median of 3.4 years, with bempedoic acid being generally well tolerated and safety, according to the study.1

About The CLEAR Outcomes Trial

Trial Name: Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo

ClinicalTrials.gov ID: NCT02993406

Sponsor: Esperion Therapeutics Inc

Completion Date: November 2022

Investigators found that LDL-C was reduced by 20%, high-sensitivity C-reactive protein was reduced by 22%, and glucose was not elevated with the drug when compared to the placebo. Further, there was a relative risk reduction of 15% for major adverse cardiac events (MACE-3), including death from cardiovascular cause, nonfatal stroke, or nonfatal myocardial infarction, 27% for nonfatal myocardial infarction, 19% for coronary revascularization, and 39% for MACE-3 in primary prevention patients, according to the press release.1

The study was a double-blind, randomized trial that included individuals who were unwilling or unable to take statins due to unacceptable adverse events, or individuals who were at high risk for cardiovascular disease. Patients in the study received either a 180 mg dosage bempedoic acid daily or the placebo.2

“[Bempedoic acid] and [bempedoic acid and ezetimibe] are once-daily, accessible, oral medications that reduce LDL-C and cardiovascular risk, but without the side effects most common to statins. [Bempedoic acid] and [bempedoic acid and ezetimibe] are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of [cardiovascular] events in both primary and secondary prevention patients,” Koenig said in the press release.1

The full results to the study were published in the New England Journal of Medicine. Currently, the label expansion is pending in Europe, with a positive opinion received from the Committee for Medicinal Products for Human Use. The company expects a final decision by the European Medicines Agency in the second quarter of 2024, according to the press release.1,2

References
  1. U.S. FDA Approves Broad New Labels for Nexletol and Nexlizet to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use. News release. Esperion. March 22, 2024. Accessed March 22, 2024. https://www.globenewswire.com/news-release/2024/03/22/2851118/0/en/U-S-FDA-Approves-Broad-New-Labels-for-NEXLETOL-and-NEXLIZET-to-Prevent-Heart-Attacks-and-Cardiovascular-Procedures-in-Both-Primary-and-Secondary-Prevention-Patients-Regardless-of-S.html
  2. Nissen SE, Lincoff AM, Brennan D, et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med. 2023;388(15):1353-1364. doi:10.1056/NEJMoa2215024
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