Posted by Michael Wonder on 25 Mar 2024
US FDA approves broad new labels for Esperion’s Nexletol and Nexlizet to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use
22 March 2024 - Esperion today announced that the US FDA has approved broad new label expansions for Nexletol (bempedoic acid) Tablets and Nexlizet (bempedoic acid and ezetimibe) tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-cholesterol 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.
