FDA Approves Bempedoic Acid-Ezetimibe Combination for ASCVD, Heterozygous FH

February 26, 2020

Regulators in the United States have approved a single-pill combination of bempedoic acid (Nexletol, Esperion) and ezetimibe, which Esperion will market as Nexlizet , the company announced today.

The new medication is indicated for use on top of maximally tolerated statins in adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who haven't met their low-density lipoprotein cholesterol (LDL-C) targets, Esperion said in a press release.

The Food and Drug administration's decision closely follows its approval of bempedoic acid as a solo agent for the same indication, and comes with similar dosing instructions and cautions.

Esperion describes bempedoic acid as the first available ATP-citrate lyase inhibitor that lowers LDL-C by suppressing cholesterol synthesis and upregulating LDL receptors. Ezetimibe inhibits cholesterol absorption in the gut.

The combination med is "the first oral, once-daily, non-statin LDL-C lowering medicine approved in the US in nearly 20 years." It will become commercially available in the United States in July, and solo bempedoic acid will go on the market March 30, the company said.

The advent of a bempedoic acid-ezetimibe combination is reminiscent of the 2004 introduction of a simvastatin-ezetimibe combo that Merck/Schering-Plough sold as Vytorin and has long since been available as a generic.

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