ANN ARBOR—Esperion Therapeutics Inc. (NASDAQ:ESPR) announced that the U.S. Food and Drug Administration (FDA) approved Nexletol (bempedoic acid) tablet, an oral, once-daily, non-statin cholesterol-lowering medicine.
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 so-called bad cholesterol. Nexletol is the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 for indicated patients.
Nexletol is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver.
“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,” said 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. Today’s approval provides them with a new medicine to go along with a healthy diet. We express our sincere gratitude to all of the patients and physicians who put their confidence in Esperion’s team of lipid experts.”
LDL-C is a waxy, fat-like substance that’s found in the body. Elevated LDL-C contributes to a buildup of this fat in the arteries and can lead to cardiovascular events including heart attack and stroke. 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.
The approval of Nexletol is supported by a global pivotal Phase 3 LDL-C lowering program conducted in more than 3,000 patients. In these studies, Nexeltol provided an average of 18 percent placebo corrected LDL-C lowering when used with moderate or high intensity statins. Results from the Phase 3 development program have been published in The New England Journal of Medicine (040 Study), and The Journal of the American Medical Association (047 Study).
Nexletol was generally well-tolerated in clinical studies. Label warnings and precautions include hyperuricemia, an excess of uric acid in the blood, with the development of gout in a small percentage of patients, as well as increased risk of tendon rupture or injury. For additional information on NEXLETOL, please see Full Prescribing Information at Esperion.com.
Eligible patients with commercial drug insurance coverage for Nexletol may pay as little as $10 per fill, up to a 3-month supply. Additionally, Esperion is committed to achieving the lowest branded tier coverage for Medicare patients. Esperion will provide resources to patients whose physician recommends treatment with Nexletol. These resources include educational materials, a dedicated call center, as well as a co-pay program for eligible patients.
Nexletol will be commercially available in the U.S., by prescription only, on March 30.
Esperion’s second LDL-C lowering medicine, the bempedoic acid / ezetimibe combination tablet, is currently under review by the U.S. FDA; the PDUFA goal date is February 26, 2020.
To listen to a management phone briefing on the FDA’s action, visit investor.esperion.com.