– New Labels Expand Treatable Population to ~70
Million Patients in U.S. –
– First LDL-C Lowering Non-Statin Indicated for
Primary Prevention Patients –
– Approvals Based on Positive CLEAR Outcomes
Data and Reflect a Highly Differentiated Product Profile –
– Positive CHMP Opinion Received; European
Cardiovascular (CV) Risk Reduction Label Determination Anticipated
in Q2 2024 –
– Conference Call and Webcast on Monday, March
25 at 8:00 a.m. ET –
Esperion (NASDAQ: ESPR) today announced that the United States
Food and Drug Administration (FDA) has approved broad new label
expansions for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET®
(bempedoic acid and ezetimibe) Tablets based on positive CLEAR
Outcomes data that include indications for cardiovascular risk
reduction and expanded LDL-C lowering in both primary and secondary
prevention patients. In addition, the enhanced labels support the
use of NEXLETOL and NEXLIZET either alone or in combination with
statins. They also include new indications for primary
hyperlipidemia, alone or in combination with a statin, and are the
only LDL-C lowering non-statin drugs indicated for primary
prevention patients.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240322544788/en/
U.S. FDA approves broad new labels for
NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid
and ezetimibe) Tablets to prevent heart attacks and cardiovascular
procedures in both primary and secondary prevention patients,
regardless of statin use. (Photo credit: Esperion)
“We are pleased to receive approval for our highly anticipated
label expansions in the U.S., which will enable more than 70
million patients to now be eligible for NEXLETOL and NEXLIZET,”
said Sheldon Koenig, President and CEO, Esperion. “Importantly,
these approvals expand the accessibility of our highly effective
drugs to primary prevention patients, or to those who are at high
risk of having a cardiovascular event, but who have not yet had
one. These approvals also eliminate the statin use requirement,
allowing patients to take NEXLETOL or NEXLIZET either with or
without a statin, which significantly reduces previously existing
prescribing limitations. We are confident these approvals position
NEXLETOL and NEXLIZET as the non-statins of first choice within the
cardiovascular risk reduction treatment paradigm.”
“We are thrilled with these significantly expanded labels and
look forward to being able to now reach millions more patients with
our life-saving drugs. In anticipation of these approvals, we have
significantly ramped up our sales force, developed a powerful suite
of new promotional materials, created a bold new consumer campaign,
enhanced our patient support programs, and continued working with
payers to ensure improved patient access.”
“NEXLETOL and NEXLIZET are once-daily, accessible, oral
medications that reduce LDL-C and cardiovascular risk, but without
the side effects most common to statins. NEXLETOL and NEXLIZET are
also the first oral non-statin LDL-C lowering drugs to be approved
by the FDA to reduce the risk of CV events in both primary and
secondary prevention patients. We believe this significantly
differentiated profile is a game changer for patients and
healthcare providers alike and that we expect sales to meaningfully
inflect as a result. I want to thank the entire Esperion team for
its unwavering commitment to patients and to getting us to this
stage. I have the utmost confidence in our future success.”
The Company’s pending label expansions in Europe remain on
track, with a positive opinion received from the Committee for
Medicinal Products for Human Use (CHMP) on March 21, 2024. The
Company anticipates a final determination by the European Medicines
Agency in the second quarter of 2024.
The U.S. approvals of NEXLIZET and NEXLETOL for cardiovascular
risk reduction and LDL-C lowering were based on data generated from
the CLEAR Outcomes trial, which was published in the New England
Journal of Medicine in March 2023, assessing the effect of NEXLETOL
on cardiovascular outcomes in nearly 14,000 patients with, or at
high risk, of cardiovascular disease. Patients were followed for a
median duration of 3.4 years and bempedoic acid (contained in
NEXLETOL and NEXLIZET) was generally safe and well tolerated. In
the study, LDL-C was reduced by 20%, hsCRP was reduced by 22%, and
glucose was not elevated by bempedoic acid compared to placebo.
Patients who received bempedoic acid in the trial experienced a
relative risk reduction of:
- 15% for MACE-3 (death from a cardiovascular cause, nonfatal
stroke, or nonfatal myocardial infarction)
- 27% for nonfatal myocardial infarction
- 19% for coronary revascularization
- 39% for MACE-3 in primary prevention patients
Conference Call and Webcast Information
Esperion will host a conference call and webcast on Monday,
March 25 at 8:00 a.m. ET to discuss these FDA approvals and its new
and expanded indications for NEXLETOL and NEXLIZET. Please click
here to participate in the conference call.
The live webcast can also be accessed on the Investors and Media
section of the Esperion website. Access to the webcast replay will
be available approximately two hours after completion of the call
and will be archived on the Company’s website for approximately 90
days.
INDICATION
NEXLIZET and NEXLETOL are indicated:
- The bempedoic acid component of NEXLIZET and NEXLETOL is
indicated to reduce the risk of myocardial infarction and coronary
revascularization in adults who are unable to take recommended
statin therapy (including those not taking a statin) with:
- established cardiovascular disease (CVD), or
- at high risk for a CVD event but without established CVD.
- As an adjunct to diet:
- NEXLIZET, alone or in combination with other LDL-C lowering
therapies, to reduce LDL-C in adults with primary hyperlipidemia,
including HeFH.
- NEXLETOL, in combination with other LDL-C lowering therapies,
or alone when concomitant LDL-C lowering therapy is not possible,
to reduce LDL-C in adults with primary hyperlipidemia, including
HeFH.
IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in patients with a
prior hypersensitivity to bempedoic acid or ezetimibe or any of the
excipients. Serious hypersensitivity reactions including
anaphylaxis, angioedema, rash, and urticaria have been
reported.
Hyperuricemia: Bempedoic acid, a component of NEXLIZET and
NEXLETOL, may increase blood uric acid levels, which may lead to
gout. Hyperuricemia may occur early in treatment and persist
throughout treatment, returning to baseline following
discontinuation of treatment. 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, a component of NEXLIZET and
NEXLETOL, is associated with an increased risk of tendon rupture or
injury. Tendon rupture may occur more frequently in patients over
60 years of age, in those taking corticosteroid or fluoroquinolone
drugs, in patients with renal failure, and in patients with
previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the
first sign of tendon rupture. Consider alternative therapy in
patients who have a history of tendon disorders or tendon
rupture.
The most common adverse reactions in the primary hyperlipidemia
trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in
≥2% of patients and greater than placebo were upper respiratory
tract infection, muscle spasms, hyperuricemia, back pain, abdominal
pain or discomfort, bronchitis, pain in extremity, anemia, and
elevated liver enzymes.
Adverse reactions reported in ≥2% of patients treated with
ezetimibe (a component of NEXLIZET) and at an incidence greater
than placebo in clinical trials were upper respiratory tract
infection, diarrhea, arthralgia, sinusitis, pain in extremity,
fatigue, and influenza.
In the primary hyperlipidemia trials of NEXLIZET, the most
commonly reported adverse reactions (incidence ≥3% and greater than
placebo) observed with NEXLIZET, but not observed in clinical
trials of bempedoic acid or ezetimibe, were urinary tract
infection, nasopharyngitis, and constipation.
The most common adverse reactions in the cardiovascular outcomes
trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at
an incidence of ≥2% and 0.5% greater than placebo were
hyperuricemia, renal impairment, anemia, elevated liver enzymes,
muscle spasms, gout, and cholelithiasis.
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized
unless the benefits of therapy outweigh the potential risks to the
fetus. Because of the potential for serious adverse reactions in a
breast-fed infant, breastfeeding is not recommended during
treatment with NEXLIZET or NEXLETOL.
Report pregnancies to Esperion Therapeutics, Inc. Adverse Event
reporting line at 1-833-377-7633.
Please see full Prescribing Information for NEXLIZET and
NEXLETOL.
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 X at
twitter.com/EsperionInc.
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.
Forward-Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding 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 net sales, profitability, and growth of
Esperion’s commercial products, clinical activities and results,
supply chain, commercial development and launch plans, the outcomes
and anticipated benefits of legal proceedings and settlements, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240322544788/en/
Esperion Contact Information: Investors: Alexis Callahan
investorrelations@esperion.com (406) 539-1762
Media: Tiffany Aldrich corporateteam@esperion.com (616)
443-8438
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