Esperion (NASDAQ: ESPR) today announced that it has submitted
Supplemental New Drug Applications (sNDA) to the U.S. Food and Drug
Administration (FDA) for the Company’s oral non-statin products
NEXLETOL and NEXLIZET. In its sNDAs, Esperion seeks to add the use
of both NEXLETOL and NEXLIZET for cardiovascular risk reduction and
also seeks to remove the statin limitation in the LDL-C indication.
The sNDA submissions are based on the landmark Cholesterol Lowering
via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes
trial which showed NEXLETOL demonstrated significant cardiovascular
risk reduction across a range of primary and second endpoints,
including a 27% risk reduction of non-fatal myocardial infarction,
a 23% risk reduction of the composite of fatal and non-fatal
myocardial infarction, a 19% risk reduction of coronary
revascularization, a 15% risk reduction of the MACE-3 composite,
and a 13% risk reduction of the MACE-4 composite. Following the
FDA’s review of the submission, it will notify the Company if the
applications are deemed complete for review by mid-August 2023. The
Company anticipates FDA approval of the sNDAs in the first half of
2024.
“These submissions mark a pivotal achievement for Esperion as we
seek to meaningfully expand the eligible patient populations for
NEXLETOL and NEXLIZET,” said Sheldon Koenig, President and Chief
Executive Officer of Esperion. “Since the announcement of the CLEAR
Outcomes results, we’ve seen accelerating adoption of our
practice-changing treatments as prescribers, patients and payers
alike recognize NEXLETOL and NEXLIZET as the clear next step after
statins, and value their potential to significantly reduce
cardiovascular risk.”
INDICATIONNEXLETOL and NEXLIZET are indicated
as adjuncts 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 and NEXLIZET on cardiovascular morbidity and mortality has
not been determined.
IMPORTANT SAFETY
INFORMATIONContraindications: NEXLETOL
has no contraindications. NEXLIZET is contraindicated in patients
with a known hypersensitivity to ezetimibe tablets.
Hypersensitivity reactions including anaphylaxis, angioedema, rash,
and urticaria have been reported with ezetimibe.
Warnings and Precautions: Hyperuricemia:
Bempedoic acid, a component of NEXLETOL and NEXLIZET, 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: Bempedoic acid
is associated with an increased risk of tendon rupture or injury.
In clinical trials, tendon rupture occurred in 0.5% of patients
treated with bempedoic acid 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 bempedoic acid. 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 or NEXLIZET at the first sign of tendon rupture. Avoid
NEXLETOL and NEXLIZET in patients who have a history of tendon
disorders or tendon rupture.
Adverse Reactions: In NEXLETOL 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.In the NEXLIZET clinical trial,
the most commonly reported adverse reactions observed with
NEXLIZET, but not observed in clinical trials of bempedoic acid or
ezetimibe, a component of NEXLIZET, and occurring more frequently
than with placebo, were urinary tract infection, nasopharyngitis,
and constipation.Adverse reactions reported in clinical trials of
ezetimibe, and occurring at an incidence greater than with placebo,
included upper respiratory tract infection, diarrhea, arthralgia,
sinusitis, pain in extremity, fatigue, and influenza. Other adverse
reactions reported in postmarketing use of ezetimibe included
hypersensitivity reactions, including anaphylaxis, angioedema,
rash, and urticaria; erythema multiforme; myalgia; elevated
creatine phosphokinase; myopathy/rhabdomyolysis; elevations in
liver transaminases; hepatitis; abdominal pain; thrombocytopenia;
pancreatitis; nausea; dizziness; paresthesia; depression; headache;
cholelithiasis; cholecystitis.
Drug Interactions: Simvastatin and Pravastatin:
Concomitant use with bempedoic acid results in increased
concentrations and increased risk of simvastatin or
pravastatin-related myopathy. Use of either NEXLETOL or NEXLIZET
with greater than 20 mg of simvastatin or 40 mg of pravastatin
should be avoided.Cyclosporine: Caution should be exercised when
using NEXLIZET and cyclosporine concomitantly due to increased
exposure to both ezetimibe and cyclosporine. Monitor cyclosporine
concentrations in patients receiving NEXLIZET and cyclosporine. In
patients treated with cyclosporine, the potential effects of the
increased exposure to ezetimibe from concomitant use should be
carefully weighed against the benefits of alterations in lipid
levels provided by NEXLIZET.
Fibrates: Coadministration of NEXLIZET with fibrates other than
fenofibrate is not recommended. Fenofibrate and ezetimibe may
increase cholesterol excretion into the bile, leading to
cholelithiasis. If cholelithiasis is suspected in a patient
receiving NEXLIZET and fenofibrate, gallbladder studies are
indicated and alternative lipid-lowering therapy should be
considered.Cholestyramine: Concomitant use of NEXLIZET and
cholestyramine decreases ezetimibe concentration. This may result
in a reduction of efficacy. Administer NEXLIZET either at least 2
hours before, or at least 4 hours after, bile acid
sequestrants.
Lactation and Pregnancy: It is not recommended that NEXLETOL or
NEXLIZET be taken during breastfeeding. Discontinue NEXLETOL or
NEXLIZET when pregnancy is recognized, unless the benefits of
therapy outweigh the potential risks to the fetus. Based on the
mechanism of action of bempedoic acid, NEXLETOL and NEXLIZET may
cause fetal harm.
Please see full Prescribing Information here.
CLEAR Cardiovascular Outcomes Trial CLEAR
Outcomes is part of the CLEAR clinical research program for
NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and
ezetimibe) Tablet. The CLEAR Program seeks to generate important
clinical evidence on the safety and efficacy of bempedoic acid, a
first in a class ATP citrate lyase inhibitor contained in NEXLETOL
and NEXLIZET and its potential role in addressing additional
critical unmet medical needs. More than 60,000 people will have
participated in the program by the time of its completion. The
CLEAR Program includes 5 label-enabling Phase III studies as well
as other key Phase IV studies with the potential to reach more than
70 million people with or at risk for CVD based on elevated
LDL-C.
Esperion Therapeutics At Esperion, we
discover, develop, and commercialize innovative medicines to help
improve outcomes for patients with or at risk for cardiovascular
and cardiometabolic diseases. The status quo is not meeting the
health needs of millions of people with high cholesterol – that is
why our team of passionate industry leaders is breaking through the
barriers that prevent patients from reaching their goals. Providers
are moving toward reducing LDL-cholesterol levels as low as
possible, as soon as possible; we provide the next steps to help
get patients there. Because when it comes to high cholesterol,
getting to goal is not optional. It is our life’s work. For more
information, visit esperion.com and esperionscience.com
and follow us on Twitter at 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 regulatory submissions and potential
approvals, marketing strategy and commercialization plans, current
and planned operational expenses, future operations, commercial
products, clinical development, including the timing, designs and
plans for the CLEAR Outcomes study and its results, plans for
potential future product candidates, financial condition and
outlook, including expected cash runway, 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, the outcomes
of legal proceedings, 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.
Esperion Contact Information: Investors: Alexis
Callahaninvestorelations@esperion.com (406) 539-1762
Media: Tiffany Aldrich corporateteam@esperion.com (616)
443-8438
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