Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and
Esperion Therapeutics, Inc. jointly announced today, that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted positive opinions for
the label update of both bempedoic acid (marketed as NILEMDO®▼) and
the bempedoic acid / ezetimibe fixed dose combination (FDC)
(marketed as NUSTENDI®▼ ), recommending their approval as
treatments to reduce low-density lipoprotein cholesterol (LDL-C)
and cardiovascular risk.2 The existing label of bempedoic acid
(NILEMDO®▼) provides authorisation for adults with primary
hypercholesterolaemia (heterozygous familial and non-familial) or
mixed dyslipidaemia, as an adjunct to diet:2
- in combination with a statin or statin with other
lipid-lowering therapies in patients unable to reach LDL-C goals
with the maximum tolerated dose of a statin, or2
- alone or in combination with other lipid-lowering therapies in
patients who are statin-intolerant, or for whom a statin is
contraindicated.2
The CHMP recommended adopting an update to this label, with
which bempedoic acid is also indicated in adults with established
or at high risk for atherosclerotic cardiovascular disease to
reduce cardiovascular risk by lowering LDL-C levels, as an adjunct
to correction of other risk factors:2
- in patients on a maximum tolerated dose of a statin with or
without ezetimibe, or2
- alone or in combination with ezetimibe in patients who are
statin-intolerant, or for whom a statin is contraindicated.2
The existing label of bempedoic acid / ezetimibe FDC tablet
(NUSTENDI®▼) provides authorisation of its use in adults with
primary hypercholesterolaemia (heterozygous familial and
non-familial) or mixed dyslipidaemia, as an adjunct to diet:2
- in combination with a statin in patients unable to reach LDL-C
goals with the maximum tolerated dose of a statin in addition to
ezetimibe2, or
- alone in patients who are either statin-intolerant or for whom
a statin is contraindicated, and are unable to reach LDL-C goals
with ezetimibe alone2,
- in patients already being treated with the combination of
bempedoic acid and ezetimibe as separate tablets with or without
statin2.
Additionally, the CHMP recommends an update of the bempedoic
acid / ezetimibe label to amend its indication in adults with
established or at high risk for atherosclerotic cardiovascular
disease to reduce cardiovascular risk by lowering LDL-C levels, as
an adjunct to correction of other risk factors2:
- in patients on a maximum tolerated dose of a statin and not
adequately controlled with additional ezetimibe treatment2 or,
- in patients who are either statin-intolerant, or for whom a
statin is contraindicated, and not adequately controlled with
ezetimibe treatment2 or ,
- in patients already being treated with the combination of
bempedoic acid and ezetimibe as separate tablets2.
“The positive CHMP opinion is a crucial milestone towards
improved treatment outcomes, as we are now able to address even
better the unmet needs of cardiovascular care and prevention among
patients in Europe. This first-in-class medicine with proven
efficacy in reducing hypercholesterolaemia and preventing
cardiovascular risks, is a testament to our tireless efforts to
help improve the cardiovascular treatment landscape. The opinion
further reinforces our confidence towards continued commitment of
supporting clinical communities and healthcare ecosystems across
Europe,” said Oliver Appelhans, Head of Europe Specialty
Division, Daiichi Sankyo Europe GmbH.
“We are thrilled with the positive CHMP opinion, which reflects
the significant cardiovascular risk reduction benefit that the
bempedoic acid global franchise brings to patients worldwide,” said
Sheldon Koenig, President and CEO, Esperion. “This
latest regulatory milestone further bolsters our efforts to work
towards delivering innovative treatment options to manage
cardiovascular risk for patients with elevated LDL-C.”
The CHMP positive opinions are based on analysis from the Phase
3 CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate
lyase (ACL)-Inhibiting Regimen) Outcomes trial1. The study enrolled
a total of 13,970 patients aged 18-85 years old, and took place at
1,250 sites in 32 countries, including 485 sites across Europe1.
Results from the Phase 3 CLEAR Outcomes trial demonstrated:
- a 13% reduction in the relative risk of major adverse
cardiovascular events defined as a four-component composite of
death from cardiovascular (CV) causes, non-fatal myocardial
infarction, non-fatal stroke or coronary revascularisation
(MACE-4)1.
- Results of the key secondary endpoints and subgroup analyses
have been published1.
The CHMP is a scientific committee of the EMA that reviews
medical product applications on their scientific and clinical
merit. The European Commission will review the CHMP opinions and is
expected to deliver its final decision in the mid of the year
2024.
INDICATIONNEXLETOL® (bempedoic acid)
Tablet/NEXLIZET® (bempedoic acid and ezetimibe) Tablet is indicated
as an adjunct to diet and statin therapy for the treatment of
primary hyperlipidemia in adults with heterozygous familial
hypercholesterolemia (HeFH) or atherosclerotic cardiovascular
disease, who require additional lowering of LDL-C.
IMPORTANT SAFETY INFORMATIONNEXLIZET is
contraindicated in patients with a known hypersensitivity to
ezetimibe tablets. Hypersensitivity reactions including
anaphylaxis, angioedema, rash, and urticaria have been reported
with ezetimibe, a component of NEXLIZET.
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, 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, a component of NEXLIZET and
NEXLETOL, is associated with an increased risk of tendon rupture or
injury. Tendon rupture occurred within weeks to months of starting
NEXLIZET or 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 NEXLIZET or NEXLETOL at
the first sign of tendon rupture. Avoid NEXLIZET or NEXLETOL in
patients who have a history of tendon disorders or tendon
rupture.
The most common adverse reactions in clinical 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 clinical trials of NEXLIZET, the most commonly reported
adverse reactions (incidence ≥3% and greater than placebo) observed
that not observed in clinical trials of bempedoic acid or
ezetimibe, were urinary tract infection, nasopharyngitis, and
constipation.
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 the
Esperion Therapeutics, Inc. Adverse Event reporting line at
1-833-377-7633.
Esperion TherapeuticsAt 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 TrialCLEAR
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 StatementsThis 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.
Media Contacts:
For Esperion: |
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For Daiichi Sankyo Europe: |
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Investors:Alexis Callahaninvestorrelations@esperion.com(406)
539-1762Media:Tiffany Aldrichcorporateteam@esperion.com(616)
443-8438 |
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Investor Relations Contact
(Japan):DaiichiSankyoIR@daiichisankyo.co.jpDr. Wolfgang Schiessl
(Europe)wolfgang.schiessl@daiichi-sankyo.eu+49 151 1714 7317Sean
Wood (Global / US)swood@webershandwick.com+1 (212) 445-8310 |
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References
_______________1 Nissen SE, et al. Bempedoic Acid and
Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J
Med. 2023. 13;388(15):1353-1364. 2 European Medicines Agency (EMA)
March 2024. Available at: Meeting highlights from the Committee for
Medicinal Products for Human Use (CHMP) 18-21 March 2024 | European
Medicines Agency (europa.eu)
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