FDA approves Nexletol to treat heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease - Esperion.

Esperion has announced that the FDA approved Nexletol (bempedoic acid) tablet, an oral, once-daily, non-statin LDL-Cholesterol (LDL-C) lowering medicine. Nexletol is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C. The effect of Nexletol on cardiovascular morbidity and mortality has not been determined. Nexletol is the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 for indicated patients. Nexletol is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver.. Comment: Nexletol faces competition, from Amgen and also Sanofi together with Regeneron, who have lowering the list prices on their respective cholesterol medicines to make progress with insurers. Novartis also recently acquired The Medicines Co. and its RNA-targeting therapy inclisiran for nearly $10 billion.