Esperion Reports Completion of Bempedoic Acid in Global P-III LDL-C Development Program for Patients with ASCVD or HeFH
Shots:
- The P-III development programs involves five studies assessing Bempedoic Acid (180 mg) (1-2-3-4 study) and bempedoic acid / ezetimibe combination pill vs PBO (053 study) in 4000 patients with ASCVD or HeFH
- Global P-III results: LDL-C lowering (18% to 31%); Reduction in hsCRP (19% to 33%); Reduction in HbA1c (0.19% to 0.31%); MACE 3/4 /5 (1.9%- 3.8%- 4.0% vs 2.3%- 4.2%- 4.6%); well tolerated and safe
- Esperion plans to submit NDA to the US FDA & MAA to EMA for bempedoic acid and the bempedoic acid / ezetimibe combination pill in LDL-C patients in Q1’19 & Q2’19 respectively
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