Full Press Release Details
Esperion Announces FDA Approval of NEXLETOL
(bempedoic acid) Tablet,
an Oral, Once-Daily, Non-Statin LDL-Cholesterol
- First Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. in Nearly 20 Years for Indicated Patients -
- NEXLETOL Lowers LDL-Cholesterol with a First-in-Class Mechanism -
- Fills an Unmet Need for Affordable Medicines for Millions of Patients with ASCVD or HeFH -
- NEXLETOL will be Commercially Available in the U.S. March 30, 2020 -
- Conference Call and Webcast on Monday, February 24 at 8:00 a.m. Eastern Time -
ANN ARBOR, Mich., February 21, 2020
(GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) announced today 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 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
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 deliver 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 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, 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
Conference Call and Webcast Information
Esperion's Lipid Management Team will host a conference call
and webcast on Monday, February 24 at 8:00 a.m. Eastern Time to discuss the approval and upcoming commercial launch.
The call can be accessed by dialing (877) 312-7508 (domestic) or (253) 237-1184 (international) five minutes prior to the start
of the call and providing the access code 4088218. A live audio webcast can be accessed on the investors and media section of
the Esperion website at investor.esperion.com. Access to the webcast replay will be available approximately two hours after
completion of the call and will be archived on the Company's website for approximately 90 days.
NEXLETOLTM (bempedoic acid) Tablet
NEXLETOL is a first-in-class ATP Citrate
Lyase (ACL) inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptors. Completed Phase
3 studies conducted in more than 3,000 patients, with over 2,000 patients treated with NEXLETOL, demonstrated an average 18 percent
placebo corrected LDL-C lowering when used in patients on moderate or high-intensity statins. NEXLETOL is the first oral, once-daily,
non-statin LDL-C lowering medicine approved in the U.S. in nearly 20 years for patients with ASCVD or HeFH. NEXLETOL was approved
by the FDA in February 2020.
Indication and Limitation of Use
NEXLETOL is indicated
as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia
or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. The effect of NEXLETOL on cardiovascular
morbidity and mortality has not been determined.
Important Safety Information
are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088 or report side effects to Esperion at 833-377-7633 (833 ESPRMED).
CLEAR Cardiovascular Outcomes
The effect of NEXLETOL
on cardiovascular morbidity and mortality has not been determined. Esperion initiated a global cardiovascular outcomes trial (CVOT)
to assess the effects of NEXLETOL on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular
disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin and are considered "statin
averse." The CVOT - known as CLEAR Cardiovascular Outcomes Trial - is an event-driven, global, randomized, double-blind,
placebo-controlled study that completed enrollment in August 2019 of 14,032 patients with hypercholesterolemia and high CVD risk
at over 1,400 sites in 32 countries.
Esperion Therapeutics
scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at
Esperion is committed to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular
disease, the leading cause of death around the world. For more information, please visit http://www.esperion.com and
Esperion Therapeutics'
Commitment to Patients with Hyperlipidemia
High levels of LDL-C can
lead to a build-up of fat and cholesterol in and on artery walls (known as atherosclerosis), potentially leading to cardiovascular
events, including heart attack or stroke. In the U.S., 96 million people, or more than 37 percent of the adult population, have
elevated LDL-C. There are approximately 18 million people in the U.S. with atherosclerotic cardiovascular disease (ASCVD) or heterozygous
familial hypercholesterolemia (HeFH) living with elevated levels of LDL-C despite taking
maximally tolerated lipid-modifying therapy - including individuals considered statin averse - leaving them at high