FDA Expands Indications for Bempedoic Acid in CVD Prevention
The US Food and Drug Administration (FDA) has expanded the indications for bempedoic acid (Nexletol) and bempedoic acid plus ezetimibe combination (Nexlizet) to prevent heart attacks and cardiovascular procedures in both primary- and secondary-prevention patients regardless of statin use.
According to manufacturer Esperion, bempedoic acid is now indicated to reduce the risk for myocardial infarction (MI) and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with established cardiovascular disease (CVD) or who are at high risk for a CVD event but without established CVD.
As an adjunct to diet, bempedoic acid–ezetimibe is indicated alone or in combination with other low-density lipoprotein cholesterol (LDL-C)–lowering therapies to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).
Bempedoic acid is also now indicated in combination with other LDL-C–lowering therapies or alone when concomitant LDL-C–lowering therapy is not possible to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
These “highly anticipated” label expansions in the United States will allow “more than 70 million patients” to now be eligible for these medications, Sheldon Koenig, Esperion president and CEO, said in the statement.
“Importantly,” said Koenig, these approvals expand accessibility to primary prevention patients and also “eliminate the statin use requirement.”
The expanded indications for CV risk reduction and LDL-C lowering were based on data from CLEAR Outcomes trial published last year in The New England Journal of Medicine.
As previously reported by theheart.org | Medscape Cardiology, the trial of nearly 14,000 patients with or who are at high risk for CVD found that bempedoic acid lowered LDL-C by 21% in the study and reduced the composite primary endpoint (including CV death, MI, stroke, or coronary revascularization) by 13%. MI was reduced by 23%, and coronary revascularization was reduced by 19%.
Full updated prescribing information for bempedoic acid and bempedoic acid–ezetimibe can be found online.
