Esperion: FDA approves broad new labels for NEXLETOL and NEXLIZET

Esperion announced that the United States FDA has approved broad new label expansions for NEXLETOL Tablets and NEXLIZET Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients. In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either 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. The company’s pending label expansions in Europe remain on track, with a positive opinion received from the Committee for Medicinal Products for Human Use on March 21. The company anticipates a final determination by the European Medicines Agency in the second quarter of 2024.