Friday, the FDA approved broad new label expansions for Esperion Therapeutics Inc’s NEXLETOL (bempedoic acid) Tablets and NEXLIZET (bempedoic acid and ezetimibe) Tablets based on CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in primary and secondary prevention patients. 

In addition, the enhanced labels support using NEXLETOL and NEXLIZET 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.

NEXLETOL/NEXLIZET is indicated as an adjunct to diet and statin therapy for primary hyperlipidemia (lower lipids in the blood) in adults with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

“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. 

The company’s pending label expansions in Europe remain on track, with a positive opinion from the Committee for Medicinal Products for Human Use. The company anticipates a final determination by the European Medicines Agency in the second quarter of 2024.

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, assessing the effect of NEXLETOL on cardiovascular outcomes in nearly 14,000 patients with, or at high risk, of cardiovascular disease. 

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:

15% for MACE-3 (death from a cardiovascular cause, nonfatal stroke, or nonfatal myocardial infarction)

 27% for nonfatal myocardial infarction

 19% for coronary revascularization

 39% for MACE-3 in primary prevention patients

Price Action: ESPR shares are up 19.6% at $2.73 during the premarket session on the last check Monday.

Illustration of Phrama lab worker created with MidJourney.