Esperion announces Otsuka submitted NDA to Japanese MHLW for bempedoic acid

Esperion (ESPR) announced that Otsuka Pharmaceutical (OSUKF) has submitted a New Drug Application, NDA, to the Japanese Ministry of Health, Labour and Welfare, MHLW, for the manufacture and sale of bempedoic acid in Japan for the treatment of hypercholesterolemia and familial hypercholesterolemia. In the preliminary results of its Japanese Phase 3 trial, the percentage change from baseline in LDL-C at Week 12, the primary endpoint, was -25.25 percent in the group receiving bempedoic acid group and -3.46 percent in the placebo group, demonstrating positive outcomes with statistical significance compared to placebo. Furthermore, the safety and tolerability of bempedoic acid were consistent with findings from previous trials, and no serious adverse events were observed.