The FDA has approved label enhancements for Esperion Therapeutics’ bempedoic acid (Nestretol) tablets and bempedoic acid and ezetimibe combination (Nexlisette) 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 low-density lipoprotein cholesterol (LDL-C) lowering in both primary and secondary prevention patients. Masu.

The enhanced label also supports the use of both drugs alone or in combination with statins and includes a new indication for primary hyperlipidemia alone or in combination with statins. Nestretol and Nexlisette are the only LDL-C-lowering nonstatin drugs indicated for patients in need of primary prevention.

“Importantly, 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 a cardiovascular event. ” said Sheldon Koenig, President and CEO of Esperion. therapeutic drug. “These approvals also eliminate the requirement for statin use, allowing patients to take Nexletor or Nexlisette with or without a statin, significantly reducing prescribing restrictions that existed previously. We believe these approvals position Nector and Nexlisette as first-line non-statin drugs in the cardiovascular risk reduction treatment paradigm.”

The CLEAR Outcomes trial evaluated the impact of bempedoic acid on cardiovascular disease outcomes over a median of 3.4 years in approximately 14,000 patients with or at high risk for cardiovascular disease. Bempedoic acid had a good safety profile and was well tolerated by patients. The study found that bempedoic acid reduced LDL-C by 20%, reduced high-sensitivity C-reactive protein by 22%, and did not increase blood sugar levels compared to placebo. . Patients receiving bempedoic acid experienced a significant relative risk reduction of:

• 15% reduction in MACE-3, which includes cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction
• 27% reduction in non-fatal myocardial infarction
• 19% reduction in coronary revascularization procedures
• 39% reduction in MACE-3 in primary prevention patients

According to a news release, Esperion is poised to meet the anticipated surge in demand, with Nestletol and Nexlisette offering lower LDL-C and reduced cardiovascular risk without the common side effects associated with statins. He believes that differentiated profiles will revolutionize treatment. landscape.

This approval is not limited to the US market. Esperion’s pending label expansion in Europe is moving forward after receiving a positive opinion from the Committee for Medicinal Products for Human Use. The company expects a final decision from the European Medicines Agency in the second quarter of 2024.

reference

The US FDA has approved a broad new label for Nexletol and Nexlisette to prevent heart attacks and cardiovascular procedures in patients for both primary and secondary prevention, 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