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The U.S. Food and Drug Administration (FDA) approved Esperion’s NEXLETOL™ (bempedoic acid) tablet, an oral, once-daily, non-statin LDL-Cholesterol (LDL-C) lowering medicine and NEXLIZET™, the bempedoic acid/ezetimibe combination tablet also destined to lower LDL-C.
LDL-C is a waxy, fat-like substance 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 – February 21st – and Nexlizet – February 26th – came after the FDA also approved, earlier this month, the first treatment for children with peanut allergies — one of the most common food allergies in the world.
The drug, Palforzia, is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. The FDA approved the drug, developed by Aimmune Therapeutics, for use in patients with a confirmed diagnosis of peanut allergy.
In February, the FDA also approved a software that will make it easier for healthcare staff to take echocardiograms.
The technology, developed by San Francisco-based artificial intelligence startup Caption Health, will help more hospitals take ultrasound pictures of the heart, a skill that is usually limited.
NEXLETOL is the first oral, once-daily, non-statin LDL-C lowering medicine to be 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 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 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.”
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 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. 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.
NEXLETOL will be commercially available in the U.S., but only by prescription, on March 30, 2020.
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’s second LDL-C lowering medicine, NEXLIZET™, the bempedoic acid / ezetimibe combination tablet, has also been approved by the FDA, the announcement being made on February 26, 2020.
NEXLIZET 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 NEXLIZET on cardiovascular morbidity and mortality has not been determined. NEXLIZET is the first non-statin, LDL-C lowering combination medicine ever approved.
“The approval of NEXLIZET underscores Esperion’s commitment to providing patients and their healthcare providers with innovative non-statin medicines that fit into their everyday routines to lower elevated levels of bad cholesterol in adult patients with ASCVD or HeFH on maximally tolerated statins. This is the first non-statin combination medicine ever approved for lowering LDL-C,” said Tim M. Mayleben, president and chief executive officer of Esperion. “We are truly grateful to all of the patients and healthcare providers who put their confidence in Esperion’s team of lipid experts.”
NEXLIZET was generally well-tolerated in a pivotal Phase 3 study. Label warnings and precautions include hyperuricemia, with the development of gout in a small percentage of patients, as well as an increased risk of tendon rupture or injury. The most common adverse events reported in the development program (incidence ≥ 2% and greater than placebo) were generally reported at similar rates to patients who received a placebo and included upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, elevated liver enzymes, diarrhea, arthralgia, sinusitis fatigue, influenza. The majority of adverse events reported with NEXLIZET were mild to moderate in severity.
NEXLIZET will be commercially available for U.S. patients in July 2020, by prescription only.