With USFDA approval in Hand, Esperion to launch Non-Statin Cholesterol drug NEXLETOL for as low as 10 dollars

–Ann Arbor: Esperion announced that the U.S. Food and Drug Administration (FDA) approved NEXLETOL™ (bempedoic acid) tablet, an oral, once-daily, non-statin LDL-Cholesterol (LDL-C) 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 effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined. 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 chief executive officer 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 FDA approval of NEXLETOL provides an important option for patients living with elevated LDL-C and ASCVD or increased risk for cardiovascular disease because of HeFH," said Christie M. Ballantyne, M.D., chairman of Esperion's Phase 3 Executive Committee and professor and chief of cardiology at Baylor College of Medicine in Houston. "There are millions of patients who are unable to reach their LDL-C targets despite available medicines. NEXLETOL is the first oral, once-daily, non-statin treatment option for indicated patients in nearly two decades."

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, NEXLETOL provided an average of 18 per cent 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, with the development of gout in a small percentage of patients, as well as increased risk of tendon rupture or injury. Overall in Phase 3 studies, the adverse events reported most frequently in patients who received NEXLETOL were generally reported at similar rates in patients who received placebo. The most common adverse events reported with NEXLETOL (incidence ≥ 2% and greater than placebo) were upper respiratory tract infections, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes. The majority of adverse events reported with NEXLETOL were mild to moderate in severity and balanced in occurrence with adverse events in patients receiving placebo. For additional information on NEXLETOL, please see Full Prescribing Information at Esperion.com.

Today's approval underscores Esperion's commitment to delivering NEXLETOL to adult patients suffering from ASCVD or HeFH and who are unable to reach their LDL-C goal on maximally tolerated statins. Esperion is working with health insurance providers to help ensure broad insurance coverage and patient access to NEXLETOL. 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 centre, 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, 2020.

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.

Read also: Alembic Pharma gets final USFDA nod for Fenofibrate tablets