FDA accepts Esperion NDAs for LDL cholesterol-lowering candidates
The FDA has accepted Esperion’s (NASDAQ:ESPR) NDAs for its bempedoic acid and bempedoic acid-ezetimibe combination tablets for the treatment of elevated low-density lipoprotein cholesterol (LDL-C).
Bempedoic acid and ezetimibe are non-statin, LDL-C lowering drugs that reduce cholesterol biosynthesis and inhibit cholesterol absorption, respectively.
Esperion's Phase 3 program included five pivotal studies to support its NDA submissions to the FDA and its marketing authorization applications to the European Medicines Agency.
The studies demonstrated that bempedoic acid reduces LDL-C by up to 30% as a monotherapy and by an additional 20% when used with maximally-tolerated statins. The combination tablet reduced LDL-C by up to 48% as a monotherapy and by 35% when used with maximally-tolerated statins.
“Our team of lipid management experts remains focused on serving the needs of the millions of patients in the U.S. not at their LDL-C goal, despite currently available therapies,” Tim Mayleben, president and CEO of Esperion, said in a statement.
Esperion is currently conducting a global cardiovascular outcomes trial and, if positive, plans to submit the results to health authorities in 2022 for inclusion in product labels.