The FDA has updated the LDL-c lowering indication for bempedoic acid and the combination tablet of bempedoic acid and ezetimibe.

The FDA has approved an update of the LDL-c lowering indication for bempedoic acid and the combination tablet of bempedoic acid and ezetimibe.

The updated label adds primary hyperlipidemia as a qualifier for existing approved populations. Additionally, maximally tolerated statin requirement has been removed. Also, the prior limitation of use stating “the effect of bempedoic acid or the tablet of bempedoic acid with ezetimibe on cardiovascular morbidity and mortality has not been determined” has also been removed.

Source: press release Esperion Therapeutics, December 13, 2023