Esperion Therapeutics declared that the US Food and Drug Administration (FDA) has approved a label expansion for two of its tablets, Nexletol (bempedoic acid) tablets and Nexlizet (bempedoic acid and ezetimibe).
The two once-daily, oral tablets are now available for the reduction of cardiovascular risk and expanded low-density lipoprotein C (LDL-C) lowering in both primary and secondary prevention patients. The drugs can now also be used in combination with statins. The upgraded label also includes treatment for primary hyperlipidaemia, alone or in combination with a statin.
The recent changes make Nexletol and Nexlizet the only approved LDL-C lowering non-statin drugs indicated for primary prevention patients, as per a 22 March company press release. The FDA first approved Nexletol in February 2020 for the treatment of hypercholesterolaemia based on data from two clinical trials (NCT02666664 and NCT02991118).
The FDA approval was based on data from the Phase III CLEAR Outcomes study (NCT02993406), which assessed the use of the two bempedoic acid therapies on cardiovascular events. In the trial, data demonstrated that Nexletol and Nexlizet were both well-tolerated while reducing LDL-C by 20% and significantly reducing the risk of major adverse cardiovascular events compared to the placebo group.
Esperion is also pursuing label expansions in Europe, recently receiving a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 21 March. The Michigan-headquartered company forecasts an approval in Q2 2024. In the EU, Nexletol is under the brand name Nilemdo while Nexlizet is known as Nustendi. The EMA first approved the drug in January 2020. In addition, Esperion partnered with Daichi Sankyo for its EU development, amending their relationship earlier this year.
The active ingredient of both therapies, bempedoic acid, is a prodrug that becomes activated in the liver. The drug lowers LDL-C through adenosine triphosphate-citrate lyase (ACL) inhibition.
