FDA Expands Labels for Nexletol, Nexlizet to Prevent Heart Attacks and Cardiovascular Procedures

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This expansion applies to the estimated 70 million patients who need either primary or secondary prevention, regardless of statin use.

The FDA has approved label expansions for Esperion Therapeutics’ bempedoic acid (Nexletol) tablets and combination bempedoic acid and ezetimibe (Nexlizet) tablets, according to an Esperion news release.

FDA Approved | Image credit: Olivier Le Moal – stock.adobe.com

This approval is based on positive data from the CLEAR Outcomes trial, with enhanced indications for cardiovascular risk reduction and expanded low-density lipoprotein cholesterol (LDL-C) lowering in both primary- and secondary-prevention patients.

The enhanced labels also support the use of both drugs alone or in combination with statins, and include new indications for primary hyperlipidemia alone or in combination with a statin. Nexletol and Nexlizet are the only LDL-C–lowering nonstatin drugs indicated for patients who need primary prevention.

“Importantly, 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,” stated Sheldon Koenig, president and CEO of Esperion Therapeutics. “These approvals also eliminate the statin use requirement, allowing patients to take Nexletol or Nexlizet either with or without a statin, which significantly reduces previously existing prescribing limitations. We are confident these approvals position Nexletol and Nexlizet as the nonstatins of first choice within the cardiovascular risk-reduction treatment paradigm.”

The CLEAR Outcomes trial assessed the impact of bempedoic acid on cardiovascular outcomes in nearly 14,000 patients with or at high risk of cardiovascular disease, over a median 3.4 years. Bempedoic acid demonstrated a favorable safety profile and was well tolerated by patients. The study revealed notable reductions in LDL-C by 20%, high-sensitivity C-reactive protein by 22%, and no elevation in glucose levels when bempedoic acid was administered compared with placebo. Patients who received bempedoic acid experienced significant relative risk reductions, including:

15% reduction for MACE-3, comprising death from a cardiovascular cause, nonfatal stroke, or nonfatal myocardial infarction
27% reduction for nonfatal myocardial infarction
19% reduction for coronary revascularization
39% reduction for MACE-3 in primary prevention patients

According to the news release, Esperion is prepared to meet the anticipated surge in demand and believes that the differentiated profiles of Nexletol and Nexlizet—which offer LDL-C reduction and cardiovascular risk reduction without the common adverse effects associated with statins—will revolutionize the treatment landscape.

The approval is not limited to the US market; Esperion's pending label expansions in Europe are progressing, with a positive opinion received from the Committee for Medicinal Products for Human Use. The company expects a final determination from the European Medicines Agency in the second quarter of 2024.

Reference

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 Therapeutics. March 22, 2024. Accessed March 22, 2024. https://www.esperion.com/news-releases/news-release-details/us-fda-approves-broad-new-labels-nexletolr-and-nexlizetr-prevent