The label expansions are for the prevention of heart attacks and cardiovascular procedures in primary as well as secondary prevention patients, irrespective of the use of statins
The product shot of Esperion’s Nexletol and Nexlizet tablets. (Credit: Esperion)
The US Food and Drug Administration (FDA) has approved the new label expansions for Esperion Therapeutics’ Nexletol (bempedoic acid) tablets and Nexlizet (bempedoic acid and ezetimibe) tablets.
The expansions are for the prevention of heart attacks and cardiovascular procedures in both primary and secondary prevention patients, irrespective of statin use.
This includes indications for expanded low-density lipoprotein cholesterol (LDL-C) lowering in primary and secondary prevention patients as well as expanded indications for cardiovascular risk reduction.
Additionally, the enhanced labels support the use of the two medications either alone or in combination with statins. They also include new indications for primary hyperlipidaemia alone or in combination with a statin.
Nexletol and Nexlizet are said to be the only LDL-C lowering non-statin therapies for primary prevention patients.
The approval was based on positive results from the CLEAR Outcomes trial.
The study evaluated cardiovascular results in around 14,000 patients with, or at high risk, of cardiovascular disease over a median duration of 3.4 years.
Nexletol and Nexlizet, which contain bempedoic acid, were well tolerated and found safe in the study.
As per the results, LDL-C was lowered by 20%, high-sensitivity C-reactive protein (hsCRP) came down by 22%, with no elevation in glucose levels by bempedoic acid in comparison to placebo.
Esperion CEO and president Sheldon Koenig said: “We are pleased to receive approval for our highly anticipated label expansions in the US, which will enable more than 70 million patients to now be eligible for Nexletol and Nexlizet.
“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.”
Esperion said that its pending label extensions in Europe are still on track with a positive decision from the Committee for Medicinal Products for Human Use (CHMP) in place.
The company expects the European Medicines Agency to make a final decision in Q2 2024.