Bempedoic Acid / Ezetimibe Fixed Dose Combination
Esperion is also pursuing development of a complementary, convenient, consistent, once-daily, oral LDL-C lowering fixed dose combination pill of 180 mg of bempedoic acid and 10 mg of ezetimibe. This highly effective non-statin combination pill is the Company’s lead product in development to significantly reduce elevated levels of LDL-C in patients who are not adequately treated with current lipid-modifying therapies, including those patients considered statin intolerant.
The LDL-C lowering efficacy profile of this product is comparable to that of other recently approved injectable therapies, and the bempedoic acid / ezetimibe combination pill also reduces hsCRP. In June 2016, the Food and Drug Administration (FDA) accepted submission of an Investigational New Drug application (NDA), and formulation of the combination pill has been selected for development and commercialization.
Esperion announced in June 2017 plans to initiate a single global pivotal Phase 3 bridging study (1002FDC-053) for the bempedoic acid / ezetimibe combination pill that will be conducted concurrently with the ongoing global pivotal Phase 3 program for bempedoic acid. The Phase 3 bridging study will support approval for an LDL-C lowering indication in both the U.S. and Europe. The randomized, double-blind, placebo-controlled study is expected to enroll up to 350 patients with hypercholesterolemia and with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH), including high cardiovascular risk primary prevention patients, whose LDL-C is not adequately controlled. Additional design details for this study will be provided upon initiation by the fourth quarter of 2017, with top-line results expected by the fourth quarter of 2018.
In tandem with the NDA submission for bempedoic acid, the company plans to submit a NDA for an LDL-C lowering indication for the bempedoic acid / ezetimibe combination pill through the abbreviated 505(b)(2) pathway by the first quarter of 2019. The company also expects to submit a Marketing Authorization Application (MAA) for an LDL-C lowering indication for the bempedoic acid / ezetimibe combination pill, consistent with the European Medicines Agency’s “Guideline on Clinical Development of Fixed Combination Medicinal Products”.