FDA clears first-in-class high cholesterol drug

February 24, 2020

Treatment is first non-statin LDL-C lowering treatment approved in years.

A first-in-class, non-statin drug to lower cholesterol will soon be on the market after receiving FDA approval

The agency cleared bempedoic acid (Nexletol, Esperion), an oral, once-daily, non-stain, LDL-Cholesterol lowering medication. The drug is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver, Esperion said in a press release.

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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.

It is the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 for indicated patients, Esperion said. It will be on the market on March 30.

“Nexletol delivers upon a commitment we’ve made to millions of patients for a new treatment alternative if they struggle with bad cholesterol and have ASCVD or HeFH,” says Tim Mayleben, president and CEO of Esperion. “Even with maximally tolerated statins, which may mean no statin at all, some of these patients can’t achieve their LDL-C goals.”

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Despite standard of care treatments, including statin therapy, it is estimated that nearly 15 million patients in the US cannot achieve guideline recommended LDL-C levels, according to Esperion.

The approval of Nexletol is supported by a global pivotal Phase 3 LDL-C lowering program conducted in more than 3,000 patients. Nexletol provided an average of 18% placebo corrected LDL-C lowering when used with moderate or high intensity statins.

Esperion said it is working with health insurance providers to “help ensure broad insurance coverage and patient access to Nexletol.” Plus, it is committed to achieving the lowest branded tier coverage for Medicare patients.

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