Esperion Wins FDA Approval for Oral, Cholesterol-Lowering Drug
The U.S. Food and Drug Administration approved Michigan-based Esperion’s oral, once-daily, non-statin LDL-Cholesterol (LDL-C) lowering medicine, Nexletol (bempedoic acid).
The approval marks the first oral, once-daily, non-statin LDL-C lowering medicine given the green light by the regulatory agency since 2002 for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C. Nexletol is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver.
The company is planning for its drug to hit the streets by the end of March in order to provide a new option for patients with high cholesterol. Nexletol will go head to head with other anti-cholesterol drugs, including the PCSK9 inhibitors Praluent and Repatha. Both of those are injectables and have a higher price point than Nexletol will have. With a lower cost for patients and being an oral pill, Experion is hoping that will win favor with prescribers. The company said it is working with insurers to have a price point of $10 for a three-month supply. Additionally, Esperion said it is committed to achieving the lowest branded tier coverage for Medicare patients.
The PCSK9 inhibitors aren’t the only cholesterol-lowering medications Nexletol will be taking on in the market. The oral drug will also face off against Amarin’s fish oil-based Vascepa, which was approved in December as an adjunct to maximally tolerated statin therapy to reduce cardiovascular risk.
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The approval of Nexletol is supported by a global pivotal Phase III LDL-C lowering program conducted in more than 3,000 patients. In these studies, NEXLETOL provided an average of 18% placebo corrected LDL-C lowering when used with moderate or high-intensity statins, the company said. Additionally, in patients not on statin background therapy and considered statin intolerant, decreased LDL-C by 25% compared to placebo.
Despite standard of care treatments, including statin therapy, it is estimated nearly 15 million patients (approximately one in four patients) in the U.S. cannot achieve guideline recommended LDL-C levels, Esperion said in its announcement.
Tim Mayleben, president and chief executive officer of Esperion, said the approval of Nexletol delivers on a commitment the company made to patients with high cholesterol and who have ASCVD or HeFH.
“Even with maximally tolerated statins, which may mean no statin at all, some of these patients can’t achieve their LDL-C goals. Today’s approval provides them with a new medicine to go along with a healthy diet,” Mayleben said in a statement.
In addition to the approval of Nexletol, Esperion is also awaiting a decision from the FDA on its second LDL-C lowering medicine, a combination tablet of bempedoic acid and ezetimibe combination tablet. A decision on that medication is expected to be made by Wednesday, Feb. 26. In clinical studies, the combination tablet showed a 29% placebo corrected LDL-C lowering when used with maximally tolerated statins, a 44% LDL-C lowering with no background statin, and a 34% reduction in high sensitivity C-reactive protein (hsCRP).