Esperion Therapeutics (ESPR) said Tuesday that its bempedoic acid has been submitted by Otsuka Pharmaceutical to the Japanese Ministry of Health, Labour, and Welfare for approval to treat hypercholesterolemia and familial hypercholesterolemia.
Esperion said the submission was based on preliminary results from a late-stage study, in which bempedoic acid showed statistical significance in reducing LDL-C compared to placebo.
Otsuka acquired exclusive development and commercialization rights for bempedoic acid in Japan from Esperion in 2020, Esperion said.