On Friday, the F.D.A. Esperion Therapeutics Inc. ESPR NEXLETOL (bempedoic acid) tablets and NEXLIZET (bempedoic acid and ezetimibe) tablets are based on CLEAR outcomes data, including indications for extended cardiovascular risk reduction and LDL-C lowering in primary and secondary prevention patients.

Additionally, the enhanced labeling supports the use of NEXLETOL and NEXLIZET alone or in combination with statins.

These include new indications for primary hyperlipidemia, either alone or in combination with statins, making it the only LDL-C-lowering non-statin drug indicated for primary prevention patients.

NEXLETOL/NEXLIZET is used to treat primary hyperlipidemia (blood lipid It is indicated as an adjunct to dietary therapy and statin therapy for the treatment of (decreased)

“We are pleased to receive approval for this long-awaited expansion in the U.S., which will now bring NEXLETOL and NEXLIZET to more than 70 million patients,” said Sheldon Koenig, President and CEO. It will become.”

The company’s pending label expansion in Europe is on track with a positive opinion from the Committee for Medicinal Products for Human Use. The company expects a final decision by the European Medicines Agency in the second quarter of 2024.

The U.S. approval of NEXLIZET and NEXLETOL for cardiovascular risk reduction and LDL-C lowering demonstrates the effects of NEXLETOL on cardiovascular outcomes in approximately 14,000 patients with cardiovascular disease or at high risk for cardiovascular disease. Based on data from the evaluated CLEAR Outcomes trial.

In this study, bempedoic acid reduced LDL-C by 20%, hsCRP by 22%, and did not increase blood glucose levels compared to placebo.

Patients who received bempedoic acid in the trial experienced a relative risk reduction of:

• 15% for MACE-3 (death due to cardiovascular disease, non-fatal stroke, or non-fatal myocardial infarction)
• 27% for non-fatal myocardial infarction
• 19% for coronary revascularization;
• MACE-3 rate in primary prevention patients is 39%

Price action: ESPR stock rose 19.6% to $2.73 during the premarket session at last check on Monday.

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