Full Press Release Details
Esperion Announces FDA Approval of the NEXLIZET
(bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine
LDL-C by 38 Percent Compared to Placebo when Added on to Maximally Tolerated Statins -
LDL-Cholesterol Lowering Combination Medicine Ever Approved -
Second Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. Following NEXLETOL (bempedoic
on February 21, 2020 -
- Further Underscores
Esperion's Commitment to Patient Affordability -
and Webcast on Thursday, February 27 at 8:00 a.m. Eastern Time -
ANN ARBOR, Mich., Feb. 26, 2020 (GLOBE NEWSWIRE) --
Esperion (NASDAQ:ESPR) today announced that the U.S. Food and Drug Administration (FDA) approved NEXLIZET (bempedoic acid
and ezetimibe) tablet, an oral, once-daily, non-statin LDL-Cholesterol (LDL-C), lowering medicine. 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. This approval follows the approval of NEXLETOL (bempedoic acid) tablet last week.
NEXLIZET contains bempedoic acid and ezetimibe and
lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption
"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."
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, it is estimated nearly 15 million ASCVD or HeFH patients on maximally
tolerated statins in the U.S. cannot achieve guideline recommended LDL-C levels.
"NEXLIZET provides significant
additional LDL-C lowering for adult patients with ASCVD or HeFH when added to maximally tolerated statin medicine, including those
patients for whom maximally tolerated statin may be no statin at all," 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. "I believe this
one-of-a-kind combination medicine which has two complementary, non-statin medications can provide highly effective additional
reductions in LDL-C when added to statin therapy. It also has the conventional, oral, once-daily administration which can prove
beneficial to patients struggling to meet their cholesterol goals with the currently available statin options in their daily regimen."
The approval of NEXLIZET is supported by the Phase
3 Fixed Combination Drug Product LDL-C Lowering program, as well as safety data from the NEXLETOL (bempedoic acid) tablet global
pivotal Phase 3 LDL-C lowering program and the existing ezetimibe safety profile. NEXLIZET lowered LDL-C by a mean of 38 percent
compared to placebo when added on to maximally tolerated statins. Results have been published in The European Journal of Preventative
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 in patients who received placebo and were 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. For additional information on NEXLIZET, please see Full
Prescribing Information at Esperion.com.
Today's approval further underscores Esperion's
commitment to deliver our medicines to adult patients suffering from ASCVD or HeFH and who are unable to reach their LDL-C goals
on maximally tolerated statins. Esperion is working with health insurance providers to help ensure broad insurance coverage and
patient access to our medicines. Eligible patients with commercial drug insurance coverage for our medicines may pay as little
as $10 per fill, up to a 3-month supply. To ensure access, both NEXLETOL and NEXLIZET will be priced at parity. 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 (bempedoic acid) or NEXLIZET. These resources include educational
materials, a dedicated call center, as well as a co-pay program for eligible patients.
NEXLIZET will be commercially available for U.S. patients
in July 2020. NEXLETOL will be commercially available for U.S. patients on March 30, 2020. Both NEXLETOL and NEXLIZET will be
available by prescription only.
Conference Call and Webcast Information
Esperion's Lipid Management Team will host a conference
call and webcast on Thursday, February 27 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 1079274. 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.
NEXLETOL (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
Warnings and Precautions:
Elevations in serum uric acid have occurred. Assess uric acid levels periodically as clinically indicated. Monitor for signs and
symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. The risk for gout events with NEXLETOL
(bempedoic acid) tablet was higher in patients with a prior history of gout although gout also occurred more frequently than placebo
in patients treated with NEXLETOL (bempedoic acid) tablet who had no prior gout history.
Tendon rupture has occurred. Discontinue NEXLETOL (bempedoic acid) tablet at the first sign of tendon rupture. Avoid NEXLETOL
(bempedoic acid) tablet in patients who have a history of tendon disorders or tendon rupture.
The most common (incidence 2% and greater
than placebo) adverse reactions are upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain
or discomfort, bronchitis, pain in extremity, anemia and elevated liver enzymes.
| Avoid concomitant use of NEXLETOL with simvastatin greater than 20 mg. | ||
| Avoid concomitant use of NEXLETOL with pravastatin greater than 40 mg. |
You 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).
Please see the full Prescribing Information
for NEXLETOL by clicking here.
(bempedoic acid and ezetimibe) Tablet
NEXLIZET contains bempedoic acid and ezetimibe and lowers elevated
LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine.
Phase 3 data demonstrated NEXLIZET lowered LDL-C by a mean of 38 percent compared to placebo when added on to maximally tolerated
statins. NEXLIZET is the first non-statin, LDL-cholesterol lowering combination medicine ever approved. NEXLIZET was approved
by the FDA in February 2020.