The FDA approved label expansions for bempedoic acid (Nexletol) and bempedoic acid/ezetimibe (Nexlizet) so they can be used more broadly as cardiovascular prevention drugs, Esperion announced Friday.
Based on the CLEAR Outcomes trial, the two adenosine triphosphate (ATP) citrate lyase inhibitor drugs are now indicated for adults with either established atherosclerotic cardiovascular disease (CVD) or high risk for a CVD event to reduce the risk of myocardial infarction (MI) and coronary revascularization. Approval does not require patients to be on existing statin therapy.
Bempedoic acid and bempedoic acid/ezetimibe also had their indications for lowering low-density lipoprotein (LDL) cholesterol expanded to all adults with primary hyperlipidemia — not just those with heterozygous familial hypercholesterolemia or established atherosclerotic CVD requiring additional cholesterol reduction.
“We are confident these approvals position Nexletol and Nexlizet as the non-statins of first choice within the cardiovascular risk reduction treatment paradigm,” said Sheldon Koenig, president and CEO of Esperion, in the company press release.
These wider approvals may help interested patients and clinicians overcome the financial issues that have been associated with bempedoic acid in clinical practice. Anecdotally, some finding the drug too pricey, or their insurance unwilling to pay for it, have had better luck getting PCKS9 inhibitors or inclisiran (Leqvio), other non-statin alternatives for LDL cholesterol reduction.
In any case, statins are still considered the guideline-recommended frontline treatment for lipid lowering, despite common reports of muscle pain and other adverse events.
In the placebo-controlled CLEAR Outcomes trial, bempedoic acid successfully conferred some primary and secondary cardiovascular prevention for statin-intolerant patients who needed cholesterol lowering. The drug reduced the risk of major adverse cardiovascular events, namely coronary revascularizations and MI, over more than 3 years of follow-up (11.7% vs 13.3% with placebo, HR 0.87, 95% CI 0.79-0.96).
CLEAR Outcomes counted nearly 14,000 participants in total. Notably, the primary prevention patients seemed to derive greater clinical benefit from bempedoic acid than the secondary prevention cohort.
Bempedoic acid and bempedoic acid/ezetimibe are taken as once-daily oral tablets. Safety risks include hyperuricemia and tendon rupture, and the drugs are not recommended for pregnant or breastfeeding women.
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