On Friday, Esperion announced that the U.S. Food and Drug Administration (FDA) has granted approval for new label expansions for their drugs, NEXLETOL (bempedoic acid) Tablets and NEXLIZET (bempedoic acid and ezetimibe) Tablets.
The said approval for NEXLIZET and NEXLETOL was granted for their usage in cardiovascular risk reduction and LDL-C (low-density lipoprotein cholesterol) lowering. This decision was founded on data gathered from the CLEAR Outcomes trial, published in the New England Journal of Medicine in March 2023.
Updates to the product labels now include indications for cardiovascular risk reduction and more extensive LDL-C lowering, applicable to both primary and secondary prevention patients. Additionally, the updated labels endorse the independent use of NEXLETOL and NEXLIZET or their use in conjunction with statins. New indications include primary hyperlipidemia, either independently or alongside a statin. NEXLETOL and NEXLIZET are the only non-statin LDL-C lowering drugs indicated for primary prevention patients.
Esperion's President and CEO, Sheldon Koenig, expressed his satisfaction about the label expansions that have made more than 70 million patients in the U.S. eligible for NEXLETOL and NEXLIZET.
The company also revealed that their proposed label expansions in Europe are progressing as expected. Esperion has already received a positive feedback from the Committee for Medicinal Products for Human Use (CHMP) on March 21, 2024, and is expecting a conclusive determination from the European Medicines Agency in the second quarter of 2024.
