FDA approves broad new labels for Nexletol ( bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use

In addition, the enhanced labels support the use of Nexletol and Nexlizet either alone or in combination with statins. They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.

"We are pleased to receive approval for our highly anticipated label expansions in the U.S., which will enable more than 70 million patients to now be eligible for Nexletol and Nexlizet ,” said Sheldon Koenig, President and CEO. “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. 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 non-statins of first choice within the cardiovascular risk reduction treatment paradigm.”

The U.S. approvals of Nexlizet and Nexletol for cardiovascular risk reduction and LDL-C lowering were based on data generated from the CLEAR Outcomes trial, which was published in the New England Journal of Medicine in March 2023,(previously cited) assessing the effect of Nexletol on cardiovascular outcomes in nearly 14,000 patients with, or at high risk, of cardiovascular disease. Patients were followed for a median duration of 3.4 years and bempedoic acid (contained in Nexletol and Nexlizet) was generally safe and well tolerated. In the study, LDL-C was reduced by 20%, hsCRP was reduced by 22%, and glucose was not elevated by bempedoic acid compared to placebo.

Patients who received bempedoic acid in the trial experienced a relative risk reduction of: i. 15% for MACE-3 (death from a cardiovascular cause, nonfatal stroke, or nonfatal myocardial infarction), ii.27% for nonfatal myocardial infarction. iii. 19% for coronary revascularization. iv. 39% for MACE-3 in primary prevention patients.