Esperion gains FDA approval for its first drug, Nexletol

Shares of Esperion Therapeutics (Nasdaq: ESPR) closed down 8.6% at $61.76 on Friday, despite the company announcing that the US Food and Drug Administration had approved Nexletol (bempedoic acid) tablet, an oral, once-daily, non-statin LDL-Cholesterol (LDL-C) lowering medicine, its first drug to gain regulatory clearance.

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, said Esperion. It is a first-in-class ATP citrate lyase (ACL) inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver.