This non-statin, combination oral investigational therapy is designed to be used in combination with other lipid-lowering therapies for patients with primary hyperlipidemia who need additional LDL-C lowering.1
|1||Bempedoic acid inhibits cholesterol synthesis via ACL inhibition in the liver.|
|2||Ezetimibe blocks gastrointestinal cholesterol absorption via NPC1L1
(Niemann-Pick C1-Like 1) inhibition, reducing cholesterol delivery to the liver.
Based on feedback received from the FDA, Esperion completed a single, pivotal, Phase 3 bridging study (1002-053) evaluating bempedoic acid 180 mg/ezetimibe 10 mg combination tablet in 382 patients with ASCVD, or at high risk for ASCVD, taking maximally-tolerated statin therapy. This trial was completed in 2018. The Phase 3 bridging study is intended to support approval for an LDL-C lowering indication in both the US and Europe.1
Feb 26, 2019
Feb 11, 2019
Also, on Feb. 11, 2019, Esperion submitted a Marketing Authorization Application (MAA) for an LDL-C lowering indication for bempedoic acid 180 mg/ezetimibe 10 mg combination tablet consistent with the European Medicines Agency’s “Guideline on Clinical Development of Fixed Combination Medicinal Products.”