Esperion: FDA Approves Expanded Labels For NEXLETOL And NEXLIZET Tablets

(RTTNews) - Esperion (ESPR) on Friday announced that the U.S. Food and Drug Administration or FDA approved new label expansions for NEXLETOL (bempedoic acid) Tablets and NEXLIZET (bempedoic acid and ezetimibe) Tablets.

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, which was published in the New England Journal of Medicine in March 2023.

The company stated that the new labels 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.

"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, Esperion.

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 (CHMP) on March 21, 2024. The company anticipates a final determination by the European Medicines Agency in the second quarter of 2024.