Posted by Michael Wonder on 14 Dec 2023
US FDA updates LDL-C lowering indication for Esperion’s Nexletol (bempedoic acid) tablet and Nexlizet (bempedoic acid and ezetimibe) tablet
13 December 2023 - Updated label adds primary hyperlipidaemia, removes maximally tolerated statin requirement, removes limitation of use.
Esperion announced today that the US FDA has approved an updated LDL-cholesterol lowering indication for Nexletol and Nexlizet to include the treatment of primary hyperlipidaemia as a qualifier for existing approved populations.
