Bempedoic Acid + Ezetimibe (BA+EZ)
Esperion is pursuing development of a complementary, convenient, oral, once-daily LDL-C lowering fixed dose combination pill of bempedoic acid 180 mg and ezetimibe 10 mg (BA+EZ). This highly effective non-statin combination pill has been developed 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 when administered as monotherapy, and BA+EZ also reduces hsCRP. In June 2016, the Food and Drug Administration accepted submission of an Investigational New Drug application for BA+EZ, and Esperion recently completed a bioavailability study. A formulation of the BA+EZ combination pill has been selected for development and commercialization. Esperion will announce clinical development and regulatory plans for the fixed dose combination pill of BA+EZ in the first half of 2017.