FDA updates LDL-C lowering indication for Nexletol (bempedoic acid) tablet and Nexlizet (bempedoic acid and ezetimibe) tablet – Esperion

Esperion announced that the FDA has approved an updated LDL-cholesterol lowering indication for Nexletol and Nexlizet to include the treatment of primary hyperlipidemia as a qualifier for existing approved populations . Additionally, the maximally tolerated qualifier for statin use has been removed, and the prior limitation of use stating “the effect of Nexlizet or Nexletol on cardiovascular morbidity and mortality […]