Esperion Therapeutics (ESPR) said Thursday the US Food and Drug Administration has confirmed that it has enough data to proceed with phase 3 studies of bempedoic acid as a monotherapy and in combination with ezetimibe in children with heterozygous and homozygous familial hypercholesterolemia.
The company said it plans to begin phase 3 trials this year and apply for an additional six-month patent extension through June 2031.