Friday, the FDA approved broad new label expansions for Esperion Therapeutics Inc’s (NASDAQ:ESPR) 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 ...