Esperion (NASDAQ: ESPR) today announced results of pooled data from
two of the company’s Phase 3 trials were presented at the virtual
88th Annual Congress of the European Atherosclerosis Society (EAS
2020). Both trials demonstrated significant lowering of cholesterol
by NEXLETOL® (bempedoic acid) Tablets in people with the most
common form of inherited high cholesterol.1,2 The data from this
pooled analysis of over 3,000 patients with Atherosclerotic
Cardiovascular Disease (ASCVD) and/or Heterozygous Familial
Hypercholesterolemia (HeFH) were presented by Professor P. Barton
Duell, Professor of Medicine, Oregon Health & Science
University and member of Esperion’s Phase 3 Steering Committee.
During the EAS presentation, it was highlighted that NEXLETOL
significantly reduced low-density lipoprotein cholesterol (LDL-C)
by a mean of 22% compared to placebo in people with HeFH taking
maximally tolerated statins with or without other lipid-lowering
therapies (LLTs). Mean LDL-C reductions from baseline to week 12
were also significantly greater with NEXLETOL vs placebo for
patients without HeFH (placebo-corrected difference: –18%).
Consistent with previous clinical studies, NEXLETOL was generally
well tolerated in people with HeFH, with no new safety signals
seen.i HeFH is a common condition affecting over 30 million people
worldwide who are at increased risk of a cardiovascular event such
as a heart attack.3 Additionally, it was shown that
many patients with HeFH do not achieve adequate LDL-C lowering
despite multidrug therapy, demonstrating a great need for
efficacious non-statin LDL-C-lowering medications.
Approved earlier this year by the U.S. Food and Drug
Administration (FDA) and launched at the height of the COVID-19
pandemic, NEXLETOL is the first oral, once-daily, non-statin LDL-C
lowering medicine available to indicated patients in nearly 20
years. The approval of NEXLETOL was supported by a global pivotal
Phase 3 LDL-C lowering program conducted in more than 3,000
patients with ASCVD and/or HeFH. In these studies, NEXLETOL
provided an average of 18% placebo corrected LDL-C lowering when
used with moderate or high intensity statins. The most common
(incidence ≥ 2% and greater than placebo) adverse reactions were
upper respiratory tract infection, muscle spasms, hyperuricemia,
back pain, abdominal pain or discomfort, bronchitis, pain in
extremity, anemia and elevated liver enzymes. NEXLETOL is indicated
as an adjunct to diet and maximally tolerated statin therapy for
the treatment of adults with HeFH or established ASCVD who require
additional lowering of LDL-C. The effect of NEXLETOL on
cardiovascular morbidity and mortality has not yet been determined.
Please see important safety information below.
“Untreated HeFH increases the risk of ASCVD 10-20
fold compared to people who do not have HeFH, primarily
as a consequence of
severe lifelong hypercholesterolemia,” said Professor P.
Barton Duell, Professor of Medicine, Oregon Health & Science
University, Portland, OR USA, who presented the data at EAS
2020. “Aggressive LDL-C lowering is the key intervention to prevent
ASCVD events in patients with HeFH, but this is often difficult to
achieve, so new LDL-C lowering therapies are needed.”
“We know that patients with HeFH face increased risk for ASCVD,
yet according to the Familial Hypercholesterolemia Foundation, 90
percent of these patients remain undiagnosed,” said Ashley Hall,
Chief Development Officer, Esperion. “There is a growing body of
evidence demonstrating that NEXLETOL can be a part of the solution
to reduce LDL-C levels in the millions of patients with this
genetic condition, once they are aware of the problem.”
To learn more about Familial Hypercholesterolemia, we encourage
you to visit the FH Foundation, a patient-centered nonprofit
organization focused on increasing awareness of HeFH at
www.thefhfoundation.org.
The 88th EAS Congress is a virtual event due to
travel restrictions. For more information please visit
https://eas2020.com/.
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. 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.
- Adverse Reactions:• 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.
- Drug Interactions:• 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.
Esperion Therapeutics
Through 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 www.esperion.com and
follow us on Twitter at www.twitter.com/EsperionInc.
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 and 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. living with elevated
levels of LDL-C despite taking maximally tolerated lipid-modifying
therapy — including individuals considered statin averse — leaving
them at high risk for cardiovascular events2. In the United States,
more than 50 percent of atherosclerotic cardiovascular disease
(ASCVD) patients and heterozygous familial hypercholesterolemia
(HeFH) patients who are not able to reach their guideline
recommended LDL-C levels with statins alone need less than a 40
percent reduction to reach their LDL-C threshold goal3.
Esperion's mission as the Lipid Management Company is to deliver
oral, once-daily medicines that complement existing oral drugs to
provide the additional LDL-C lowering that these patients need.
Forward-Looking StatementsThis press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions of the federal securities laws, including
statements regarding the clinical development and commercialization
plans for bempedoic acid tablet, Esperion’s expectations for the
market for medicines to lower LDL-C and the impact of bempedoic
acid tablet in such market, including the commercial launch and the
market adoption of bempedoic acid tablet in the United States and
European Union. Any express or implied statements contained in this
press release that are not statements of historical fact may be
deemed to be forward-looking statements. Forward-looking statements
involve risks and uncertainties that could cause Esperion's actual
results to differ significantly from those projected, including,
without limitation, delays or failures in Esperion’s clinical
development and commercialization plans, or approval of expanded
indications, that existing cash resources may be used more quickly
than anticipated, the impact of COVID-19 on our business, clinical
activities and commercial development plans, and the risks detailed
in Esperion's filings with the Securities and Exchange Commission.
Any forward-looking statements contained in this press release
speak only as of the date hereof, and Esperion disclaims any
obligation or undertaking to update or revise any forward-looking
statements contained in this press release, other than to the
extent required by law.
References Pinkosky SL, et al. Liver- specific
ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and
attenuates atherosclerosis. Nature Communications. 2016; 7:13457.
DOI:10.1038/ncomms13457. Barton Duell P, et al. Efficacy and Safety
of Bempedoic Acid in Patients with Heterozygous Familial
Hypercholesterolemia: Analysis of Pooled Patient-level Data From
Phase 3 Clinical Trials. Presentation at the European
Atherosclerosis Society 88th Congress Virtual Meeting. October
2020. Di Taranto, MD, et al. Familial hypercholesterolemia: A
complex genetic disease with variable phenotypes. European Journal
of Medical Genetics. 2020. 63;4:103831. McGowan, MP, et al.
Diagnosis and treatment of heterozygous familial
hypercholesterolemia. Journal of the American Heart
Association. 2019. 8;24:e013225. The Task Force for the management
of dyslipidaemias of the European Society of Cardiology (ESC) and
European Atherosclerosis Society (EAS). ESC/EAS guidelines for the
management of dyslipidaemia. European Heart Journal. 2020 Jan
1;41(1):111-188. doi:10.1093/eurheartj/ehz455. Fox KM, et al.
Treatment patterns and low-density lipoprotein cholesterol (LDL-C)
goal attainment among patients receiving high- or
moderate-intensity statins. Clinical Research in Cardiology 2018;
107: 380–388. Kotseva K, et al. Lifestyle and impact on
cardiovascular risk factor control in coronary patients across 27
countries: Results from the European Society of Cardiology ESC-EORP
EUROASPIRE V registry. European Journal of Preventative Cardiology.
2019;26(8):824–835.
_______________1 Barton Duell P, et al. Efficacy and Safety of
Bempedoic Acid in Patients with Heterozygous Familial
Hypercholesterolemia: Analysis of Pooled Patient-level Data From
Phase 3 Clinical Trials. Presentation at the European
Atherosclerosis Society 88th Congress Virtual Meeting. October
2020.2 Di Taranto, MD, et al. Familial hypercholesterolemia: A
complex genetic disease with variable phenotypes. European Journal
of Medical Genetics. 2020. 63;4:103831.3 McGowan, MP, et al.
Diagnosis and treatment of heterozygous familial
hypercholesterolemia. Journal of the American Heart
Association. 2019. 8;24:e013225.
Contact:Kaitlyn Brosco
Esperioninvestorrelations@esperion.com
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