Esperion (NASDAQ: ESPR) today announced that the landmark
Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen
(CLEAR) Outcomes trial met its primary endpoint, demonstrating
statistically significant risk reduction in MACE-4 in patients
treated with 180 mg/day NEXLETOL compared to placebo.
“With the announcement of these positive topline results,
bempedoic acid becomes the first ATP-citrate lyase inhibitor to
demonstrate significant and clinically meaningful outcomes results
for patients in whom existing lipid lowering therapies fall short,”
said Sheldon Koenig, President and CEO of Esperion. “We thank the
thousands of patients and investigators worldwide for bringing this
study to a successful close. We look forward to sharing this data
with the medical community and submitting to appropriate regulatory
authorities as quickly as possible in 2023. CLEAR Outcomes further
strengthens the clinical evidence supporting the role of bempedoic
acid for patients.”
Cardiovascular disease remains the number one killer globallyi.
A large proportion of patients at risk for cardiovascular events
based on elevated LDL-cholesterol and apolipoprotein b are not
adequately treated with existing therapies. Despite recent
therapeutic advances, there remains a significant need for new
treatment options to help improve long-term cardiovascular
outcomesii.
CLEAR Cardiovascular Outcomes TrialCLEAR
Outcomes is a Phase 3, event-driven, randomized, multicenter,
double-blind, placebo-controlled trial designed to evaluate whether
treatment with bempedoic acid reduces the risk of cardiovascular
events in patients with or who are at high risk for cardiovascular
disease with documented statin intolerance (inability to tolerate
two or more statins, one at a low dose) and elevated
LDL-cholesterol levels (fasting blood LDL-C ≥ 100 (2.6 mmol/L)).
The study included over 14,000 patients at over 1,200 sites in 32
countries.
INDICATIONNEXLETOL 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. Limitations of Use: The effect of
NEXLETOL on cardiovascular morbidity and mortality has not been
determined.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions: Hyperuricemia:
NEXLETOL may increase blood uric acid levels. Hyperuricemia may
occur early in treatment and persist throughout treatment, and may
lead to the development of gout, especially in patients with a
history of gout. Assess uric acid levels periodically as clinically
indicated. Monitor for signs and symptoms of hyperuricemia, and
initiate treatment with urate-lowering drugs as appropriate.Tendon
Rupture: NEXLETOL is associated with an increased risk of tendon
rupture or injury. In clinical trials, tendon rupture occurred in
0.5% of patients treated with NEXLETOL versus 0% of patients
treated with placebo, and involved the rotator cuff (the shoulder),
biceps tendon, or Achilles tendon. Tendon rupture occurred within
weeks to months of starting NEXLETOL. Tendon rupture may occur more
frequently in patients over 60 years of age, patients taking
corticosteroid or fluoroquinolone drugs, patients with renal
failure, and patients with previous tendon disorders. 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: In clinical trials, the most
commonly reported 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. Reactions reported less frequently, but still more
often than with placebo, included benign prostatic hyperplasia and
atrial fibrillation.
Drug Interactions: Simvastatin and Pravastatin:
Concomitant use results in increased concentrations and increased
risk of simvastatin or pravastatin-related myopathy. Use with
greater than 20 mg of simvastatin or 40 mg of pravastatin should be
avoided.
Lactation and Pregnancy: It is not recommended
that NEXLETOL be taken during breastfeeding. Discontinue NEXLETOL
when pregnancy is recognized, unless the benefits of therapy
outweigh the potential risks to the fetus. Based on the mechanism
of action, NEXLETOL may cause fetal harm.
Please see full Prescribing Information here.
Esperion TherapeuticsEsperion works 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 future operations, commercial products,
clinical development, and other statements containing the words
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,”
“plan,” “predict,” “project,” “suggest,” “target,” “potential,”
“will,” “would,” “could,” “should,” “continue,” and similar
expressions. 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 the ongoing COVID-19 pandemic on
our business, revenues, results of operations and financial
condition, the net sales, profitability, and growth of Esperion’s
commercial products, 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
______________________________i Centers for Disease Control and
Prevention, National Center for Health Statistics. About Multiple
Cause of Death, 1999–2020. CDC WONDER Online Database website.
Atlanta, GA: Centers for Disease Control and Prevention; 2022.
Accessed November 2022.ii Ray KK, Ference BA, Séverin T, Blom D, et
al. World Heart Federation Cholesterol Roadmap 2022. Global Heart.
2022; X(X): X. DOI: https://doi. org/10.5334/gh.1154)
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