The FDA has approved broad new label expansions for bempedoic acid (Nexletol; Esperion Therapeutics) and bempedoic acid and ezetimibe (Nexlizet; Esperion) to reduce cardiovascular risk, both in key patient populations. Expanded reduction in protein-C (LDL-C). secondary prevention patients, according to a press release. Additionally, this approval includes an indication for primary hyperlipidemia, either alone or in combination with statins.¹

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According to a press release, these two drugs are the only LDL-C-lowering non-statin drugs indicated for primary prevention patients.¹

“These approvals expand the availability of our highly effective medicines for primary prevention patients, or patients who are at high risk for a cardiovascular event but have not yet had one. Approval also removes the requirement for statin use, allowing patients to take statins. [bempedoic acid] or [bempedoic acid and ezetimibe] Regardless of the presence or absence of statins, previous prescription restrictions will be significantly reduced.We are confident in these approval positions [bempedoic acid] and [bempedoic acid and ezetimibe] as a first-line non-statin drug in the cardiovascular risk reduction treatment paradigm,” Esperion President and CEO Sheldon Koenig said in a press release.¹

FDA approval of the new indication is based on data from the CLEAR Outcomes trial (NCT02993406), which evaluated the effects of bempedoic acid on cardiovascular outcomes in 14,000 people with or at high risk for cardiovascular disease. ing. Additionally, patients were followed for a median of 3.4 years, and bempedoic acid was generally well tolerated and safe, according to the study.¹

Researchers found that LDL-C was reduced by 20%, high-sensitivity C-reactive protein was reduced by 22%, and glucose was not increased by the drug compared to placebo. In addition, the relative risk was 15% for major adverse cardiac events (MACE-3) such as death from cardiovascular disease, non-fatal stroke, and non-fatal myocardial infarction, 27% for non-fatal myocardial infarction, and 19% for reconstructive procedures and 39% for MACE-3 in primary prevention patients, according to the press release.¹

This study was a double-blind, randomized trial in individuals unwilling or unable to take statins due to unacceptable adverse events or at increased risk of cardiovascular disease. Patients in this study received either bempedoic acid or a placebo at a dose of 180 mg per day.²

“[Bempedoic acid] and [bempedoic acid and ezetimibe] An easy-to-use, once-daily oral medication that reduces LDL-C and cardiovascular risk, but without the side effects most common with statins. [Bempedoic acid] and [bempedoic acid and ezetimibe] It is also the first oral nonstatin LDL-C lowering drug approved by the FDA to reduce the risk of: [cardiovascular] Events occur in both primary and secondary prevention patients,” Koenig said in a press release.¹

The full results of this study are New England Medical Journal. Label expansion is currently pending in Europe and has received a positive opinion from the Committee for Medicinal Products for Human Use. The company expects a final decision by the European Medicines Agency to be made in the second quarter of 2024, according to a press release.^{1, 2}

References

1. The US FDA has approved a broad new label for Nestretol and Nexlisette to prevent heart attacks and cardiovascular procedures in patients for primary and secondary prevention, 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/US-FDA-Approves-Broad-New-Labels-for -NEXLETOL and NEXLIZET – Primary and Secondary Prevention Preventing both heart attacks and cardiovascular procedures in patients – S.html

2. Nissen SE, Linkoff AM, Brennan D, et al. Bempedoic acid and cardiovascular outcomes in statin-intolerant patients. N English J Medicine. 2023;388(15):1353-1364. doi:10.1056/NEJMoa2215024