Esperion (NASDAQ: ESPR) today presented two new analyses from its
clinical development program of bempedoic acid (NEXLETOL®) at the
American College of Cardiology’s 71st Annual Scientific Session
& Expo (ACC.22).
The first analysis titled, “Safety and Efficacy of Bempedoic
Acid in Patients with Renal Impairment,” was presented by Peter P.
Toth, MD, PhD, FCCP, FAHA, FESC, FACC. This analysis of a total of
3,619 patients included in four Phase 3 studies demonstrated that
bempedoic acid 180 mg significantly lowered low-density lipoprotein
cholesterol (LDL-C) (p<0.0001) regardless of renal function.
While patients with severe renal impairment (eGFR <30
mL/min/1.73 m2) or end-stage renal disease receiving dialysis were
not recruited for these trials, bempedoic acid was effective and
generally well tolerated in the large group of patients with Stage
2 or Stage 3 renal impairment (estimated glomerular filtration
rates (eGFR) between 30 and <90 mL/min/1.73 m2).
A second analysis titled, “Safety and Efficacy of Bempedoic Acid
in Patients with Hypertension,” was presented by Keith C.
Ferdinand, MD, FACC, FAHA, FASH, FNLA. In 3,623 patients with ASCVD
included in pooled data from four Phase 3 studies, 78% had a
history of hypertension. In these patients, bempedoic acid 180 mg
significantly lowered LDL-C. Bempedoic acid was associated with
substantial decreases in LDL-C (p<0.0001) regardless of a
patient’s hypertension history. The presentation included an
analysis of a Phase 2 study of patients with hypertension, where a
significant reduction in LDL-C was found among patients with blood
pressure ≥140/90 and ≤180/110 mmHg.
“We are encouraged by the findings from our clinical development
program across Phase 2 and Phase 3 trials that bempedoic acid can
be utilized to lower LDL-C in these high risk hypertensive and
renal patients,” said JoAnne Foody, MD, FACC, FAHA, chief medical
officer of Esperion. “These additional analyses continue to
emphasize the efficacy and safety of bempedoic acid across a wide
range of at-risk patients who require additional options to lower
their LDL-C.”
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.
INDICATION 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. 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 for NEXLETOL by clicking
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. Esperion commercializes NEXLETOL® (bempedoic
acid) and NEXLIZET® (bempedoic acid and ezetimibe) Tablets and is
the leader in the development of convenient oral, once-daily
non-statin LDL-cholesterol lowering drugs for patients with high
levels of bad cholesterol. 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 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
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