Esperion Presents Important New Science Highlighting Potential Benefits of NEXLETOL® (bempedoic acid) Tablets at American Heart Association Scientific Sessions 2021
November 12 2021 - 7:00AM
Esperion (NASDAQ: ESPR) today announced the presentation of three
abstracts highlighting NEXLETOL tablets at the American Heart
Association (AHA) Scientific Sessions 2021 taking place on November
13-15, 2021.
“As one of the few companies solely focused on LDL-C lowering in
high-risk cardiovascular patients, Esperion continues to advance
the science of lipid lowering and the value of our therapies. These
presentations provide important new information for clinicians as
they look to provide oral therapies to reduce LDL-C,” said Dr.
JoAnne Foody, chief medical officer of Esperion. “The data
presented during AHA highlight not only the important LDL-C
lowering benefits of bempedoic acid across multiple patient
populations, but also highlight the potential cardiometabolic
effects of our compounds with reductions in glucose and hsCRP.
Bempedoic acid, through inhibition of the enzyme ATP citrate lyase
pathway, uniquely acts at the interface of lipid and carbohydrate
metabolism and offers promise for future targeting of patients with
cardiometabolic risk.”
In the abstract, “Factors Associated with Enhanced Low-density
Lipoprotein Cholesterol Lowering With Bempedoic Acid Among Patients
Enrolled in Phase 3 Studies,” LDL-C lowering with BA was examined
using pooled data from four Phase 3 studies in 3,488 patients on
background maximally tolerated statins. Overall, from baseline to
Week 12, BA lowered LDL-C levels comparable to that of a moderate-
or high-intensity statin (≥ 30%) in 28.9% of patients. In patients
not receiving background statins, greater than 50% of patients
achieved at least 30% LDL-C lowering with BA. A multivariate
analysis showed that many factors, including the absence of
baseline statin use, gender, history of diabetes mellitus, baseline
ezetimibe (EZE), and higher hsCRP were associated with increased
rates of achieving at least a 30% reduction in LDL-C with BA
treatment (odds ratio [95% CI], 2.49 [1.94, 3.19; P <
.0001).
In “Efficacy and Safety of Bempedoic Acid in Patients With
Metabolic Syndrome,” pooled data from four Phase 3 studies were
used to analyze the lipid-lowering efficacy, safety, and effect of
BA on glycemic parameters and hsCRP according to baseline metabolic
status. The analysis of 3,623 patients (excluding diabetes mellitus
patients) determined the incidence of treatment emergent adverse
events (TEAEs) was comparable in both subgroups. Overall, BA
demonstrated comparable safety in both metabolic subgroups and
greater lowering of LDL-C, HbA1c, and fasting plasma glucose (FPG)
levels in patients with metabolic syndrome (MetS) vs nonMetS.
The abstract, “Pharmacokinetics, Pharmacodynamics, and Safety of
Bempedoic Acid in a Phase 1 Clinical Trial in Healthy Japanese,
Chinese, and White Subjects,” analyzed data from a double-blind,
placebo-controlled study in a total of 40 healthy subjects
randomized 3:1 to receive BA or placebo. Reductions in fasting
LDL-C, non-HDL-C and hsCRP were observed with BA and the drug was
well tolerated. PK differences were explained after normalizing by
subject body weight and were not associated with any clinically
meaningful differences in the efficacy or safety profiles of
BA.
Approved by the U.S. Food and Drug Administration (FDA),
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. 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.
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. Daiichi Sankyo Europe has licensed
exclusive commercialization rights to bempedoic acid in the
European Economic Area, Switzerland, Turkey, and United Kingdom,
from Esperion.
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 TherapeuticsEsperion 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. 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. 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,
the impact of COVID-19 on our business, clinical activities and
results, supply chain, commercial development and launch 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.
Contact:Corporate Communicationscorporateteam@esperion.com
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