FDA approves Esperion’s non-statin cholesterol-lowering drug

The drug, Nexletol, is designed for use with maximally tolerated statins for lowering LDL cholesterol in patients with heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease.

The Food and Drug Administration has approved a drug designed as an adjunct to statins for lowering cholesterol.

Ann Arbor, Michigan-based Esperion said Friday that the FDA had approved Nexletol (bempedoic acid) as an adjunct to diet and as much of a statin as patients can tolerate for treating heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease, particularly adults who need additional lowering of “bad” LDL cholesterol.

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Shares of Esperion were up more than 6% on the Nasdaq after markets opened Monday.

“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,” Esperion CEO Tim Mayleben said in a statement. “Even with maximally tolerated statins, which may mean no statin at all, some of these patients can’t achieve their LDL-C goals.”

According to a slide presentation shown in a conference call with investment bank analysts Monday morning, an estimated 14.8 million patients in the U.S. who have HeFH and ASCVD require lowering of cholesterol in addition to statin therapy. It was estimated that 34.1 million Americans are on a statin.

While statins generally have benign side-effect profiles, some patients are unable to tolerate them – particularly high-intensity statins like atorvastatin and rosuvastatin – due to relatively rare side effects like new-onset diabetes and muscle symptoms. Other non-statin drugs for lowering cholesterol include PCSK9-targeting drugs such as Amgen’s Repatha (evolocumab), Sanofi’s Praluent (alirocumab) and inclisiran, developed by Alnylam Pharmaceuticals and The Medicines Company and currently under FDA review. Novartis acquired The Medicines Company in November for $9.7 billion.

In the conference call, Mayleben said the drug’s list price for payers will be $10 per day. A patient assistance program will offer the drug for as low as $10 for up to three months for eligible patients, with the goal of ensuring adherence.

“We will look closely at abandonment rates – this is critically important,” Chief Commercial Officer Mark Glickman said during the call, adding that out-of-pocket costs are a major reason for prescription abandonment.

The drug is an ATP citrate lyase inhibitor designed to lower LDL cholesterol through inhibition of cholesterol synthesis in the liver. The approval was based on results from two Phase III studies that included more than 3,000 patients showing that the drug provided an average 18% lowering of cholesterol when used with moderate- to high-intensity statins.

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