The US Food and Drug Administration (FDA) has expanded the indications for Bempedoic acid (Nexletol) and the combination of Bempedoic acid plus Ezetimibe (Nexlizet) for the prevention of heart attacks and cardiovascular interventions in both primary and secondary prevention patients regardless of the use of statins.
According to the manufacturer Esperion, Bempedoic acid is now intended to reduce the risk of myocardial infarction (MI) and coronary revascularization in adults who are unable to adhere to the recommended statin therapy (including those not taking a statin) and who have existing cardiovascular disease (CVD) with a high risk of a cardiocascular event, but without established cardiovascular disease.
As an adjunct to diet, Bempedoic acid-Ezetimibe alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies is indicated to lower LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).
Bempedoic acid is now also indicated in combination with other LDL-C lowering therapies or alone if simultaneous LDL-C lowering therapy is not feasible to lower LDL-C in adults with primary hyperlipidemia, including HeFH.
These „highly anticipated“ labeling expansions in the United States will now allow „more than 70 million patients“ to have access to these medications, said Sheldon Koenig, President and CEO of Esperion, in the statement.
„Importantly,“ Koenig said, these approvals expand access for primary prevention patients and also „eliminate the need for the use of statins.“
The expanded indications for reducing cardiovascular risk and lowering LDL-C were based on data from the CLEAR Outcomes study published last year in The New England Journal of Medicine.
As previously reported by theheart.org | Medscape Cardiology, the study with nearly 14,000 patients with or at high risk for cardiovascular disease found that Bempedoic acid in the study lowered LDL-C levels by 21% and reduced the composite primary endpoint (including cardiovascular death, MI, stroke, or coronary revascularization) by 13%. Myocardial infarction was reduced by 23% and coronary revascularization by 19%.
Complete updated prescribing information for Bempedoic acid and Bempedoic acid-Ezetimibe can be found online.