Esperion (NASDAQ: ESPR) today announced the poster presentation of
an analysis applying the validated Second Manifestations of
ARTerial disease (SMART) model1 and Cholesterol Treatment
Trialists’ (CTT) coefficient2 to pooled Phase 3 data to assess the
potential of NEXLETOL® (bempedoic acid) Tablet to reduce
cardiovascular event risk at the American College of Cardiology’s
70th Annual Scientific Session (ACC.21).
The poster, entitled “Estimated Cardiovascular Benefits of
Bempedoic Acid in Patients With Established Cardiovascular
Disease,” was presented by Dr. Laura H. Gunn, Associate Professor,
Department of Public Health Sciences, and Affiliate Faculty, School
of Data Science, University of North Carolina at Charlotte, and
Honorary Research Fellow, School of Public Health, Imperial College
London. Using the validated SMART model, Dr. Gunn and co-authors
simulated the baseline 10-year risk score for major adverse
cardiovascular events (MACE) for more than 3,000 patients with
ASCVD.3 The data were pooled from four completed pivotal Phase 3
studies of bempedoic acid, where change in low-density lipoprotein
cholesterol (LDL-C) at Week 12 was the primary endpoint.4-7
Patients were stratified into two groups: those taking maximally
tolerated statins and those considered statin intolerant. Using
observed changes in LDL-C at week 12, researchers applied the CTT
coefficient to calculate an estimated 10-year cardiovascular event
relative risk reduction rate. By applying the resulting relative
risk reduction rate to the baseline SMART risk score, researchers
were able to estimate the new absolute risk for each patient.3
In this poster presentation, among the group of patients taking
maximally tolerated statins, baseline 10-year cardiovascular event
risk based on the SMART model was estimated at 25.9% for those
treated with bempedoic acid and 26.6% for those who received
placebo. In the statin intolerant group, baseline 10-year
cardiovascular event risk based on the SMART model was estimated at
31.9% for those treated with bempedoic acid and 30.9% for those who
received placebo.3 The simulation predicted that patients treated
with bempedoic acid on top of maximally tolerated statins would
experience a 3.3% further absolute reduction in 10-year
cardiovascular event risk compared with statins alone (p<
0.0001).3-5 For statin-intolerant patients, defined as patients
receiving no more than low-dose statin including no statin, the
simulation predicted a further 6.0% absolute reduction in 10-year
cardiovascular event risk with bempedoic acid compared with placebo
(p< 0.0001).3,6-7
“Using the well-established relationship between LDL-C lowering
and ASCVD risk reduction, as well as validated models, these data
from ASCVD patients in our Phase 3 pivotal trials estimate a
significant risk reduction in major cardiovascular events with
NEXLETOL treatment,” said Ashley Hall, chief development officer of
Esperion. “These data reinforce the potential incremental
cardiovascular benefits of LDL-C lowering in high-risk ASCVD
patients.”
“Published analyses with validated models like SMART and CTT can
help inform treatment decisions now, ahead of clinical data
availability,” said Professor Kausik K. Ray, MBChB, MD, Mphil,
FRCP; Professor of Public Health at the School of Public Health,
Imperial College London; Consultant Cardiologist; member of the
CLEAR Outcomes steering committees; and senior author of the ACC
presentation. “The data in this analysis are encouraging,
particularly for physicians and their patients with ASCVD who want
to lower cardiovascular event risk but have had difficulty managing
LDL-C.”
Based on readily available baseline characteristics, the SMART
risk calculation estimates an individual ASCVD patient’s 10-year
risk of cardiovascular death, stroke, or myocardial infarction,
also known as three-point MACE. The SMART risk score was developed
based on data from a population of 5,788 patients who were part of
the SMART study in the Netherlands during a 14-year period.1 The
model was validated and updated based on pooled data from more than
18,000 patients across four continents.8 Because cardiovascular
event risk can vary greatly across patients with previous
cardiovascular disease, the SMART risk score allows physicians and
patients to better estimate individual risk to tailor treatment and
follow up.
The impact of NEXLETOL on cardiovascular morbidity and mortality
has not been determined is currently being investigated as part of
the ongoing CLEAR Outcomes study in more than 14,000
statin-intolerant patients with or at high risk for ASCVD.9
The 2020 approval of NEXLETOL in the U.S. was supported by a
global pivotal Phase 3 LDL-C-lowering program conducted in more
than 3,000 patients with ASCVD and/or heterozygous familial
hypercholesterolemia (HeFH) on maximally tolerated statins. In
these studies, NEXLETOL provided an average of 18%
placebo-corrected LDL-C lowering at week 12 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. Please see important safety information below.
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, and by the European
Commission in April 2020 under the name NILEMDO® (bempedoic acid)
with a different label.10 Daiichi Sankyo Europe has licensed
exclusive commercialization rights to bempedoic acid in the
European Economic Area, Switzerland and Turkey from Esperion, and
is the full marketing authorization holder in these
territories.
Indication and Limitation of UseNEXLETOL 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 was higher in patients with a prior history of gout
although gout also occurred more frequently than placebo in
patients treated with NEXLETOL who had no prior gout history.
- Tendon rupture has occurred. Discontinue NEXLETOL at the first
sign of tendon rupture. Avoid NEXLETOL 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
ESPERION is The Lipid Management Company. Our goal is lipid
management for everybody, that’s why we work hard to make our
medicines easy to get, easy to take and easy to have. We discover,
develop and commercialize innovative medicines and combinations to
lower cholesterol, especially for patients whose needs aren’t being
met by the status quo. Our entrepreneurial team of industry leaders
is inclusive, passionate and resourceful. We are singularly focused
on managing cholesterol so you can improve your health easily. For
more information, please visit www.esperion.com and follow us on
Twitter at www.twitter.com/EsperionInc.
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 commercialization plans for bempedoic acid
tablet. 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.
References1 Dorresteijn, Johannes A N et al.
“Development and validation of a prediction rule for recurrent
vascular events based on a cohort study of patients with arterial
disease: the SMART risk score.” Heart (British Cardiac Society)
vol. 99,12 (2013): 866-72. doi:10.1136/heartjnl-2013-303640
2 Baigent C, et al. “Efficacy and safety of more intensive
lowering of LDL cholesterol: a meta-analysis of data from 170,000
participants in 26 randomised trials.” Lancet vol. 376 (2010):
1670-1681.
3 Gunn Laura H, et al. “Estimated Cardiovascular Benefits of
Bempedoic Acid in Patients With Established Cardiovascular
Disease.” Presentation at the American College of Cardiology’s 70th
Annual Scientific Session. May 2021.
4 Ray K.K., et al. “Safety and efficacy of bempedoic acid to
reduce LDL cholesterol.” N Engl J Med vol. 380 (2019): 1022-1032.
Doi:10.1056/NEJMoa1803917
5 Goldberg, Anne C et al. “Effect of Bempedoic Acid vs Placebo
Added to Maximally Tolerated Statins on Low-Density Lipoprotein
Cholesterol in Patients at High Risk for Cardiovascular Disease:
The CLEAR Wisdom Randomized Clinical Trial.” JAMA vol. 322,18
(2019): 1780-1788. Doi:10.1001/jama.2019.16585
6 Ballantyne, Christie M et al. “Efficacy and safety of
bempedoic acid added to ezetimibe in statin-intolerant patients
with hypercholesterolemia: A randomized, placebo-controlled study.”
Atherosclerosis vol. 277 (2018): 195-203.
Doi:10.1016/j.atherosclerosis.2018.06.002
7 Laufs, Ulrich et al. “Efficacy and safety of bempedoic acid in
patients with hypercholesterolemia and statin intolerance.” JAHA
vol. 8,7 (2019): e011662. Doi:10.1161/JAHA.118.011662
8 Kaasenbrood L, et al. “Distribution of estimated 10-year risk
of recurrent vascular events and residual risk in a secondary
prevention population.” Circulation. vol. 134(19) (2016):
1419-1429.
9 Nicholls Stephen J. et al. “Rationale and design of the
CLEAR-outcomes trial: Evaluating the effect of Bempedoic acid on
cardiovascular events in patients with statin intolerance.”
American Heart Journal. vol. 235 (2021): 104-112.
https://doi.org/10.1016/j.ahj.2020.10.060.
10 European Medicines Agency. NILEMDO® Summary of Product
Characteristics. Last accessed May 2021:
https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf.
Contact:Kaitlyn Brosco Esperioncorporateteam@esperion.com
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Jun 2024 to Jul 2024
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Jul 2023 to Jul 2024