Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and
Esperion Therapeutics, Inc. jointly announced today that the
European Commission (EC) has approved the label update of both
NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid / ezetimibe
fixed-dose combination (FDC)), as treatments for
hypercholesterolemia (high levels of cholesterol) and to reduce the
risk of adverse cardiovascular events. The EC’s decisions to update
the labels of bempedoic acid and bempedoic acid / ezetimibe FDC are
based on the positive CLEAR Outcomes trial results and makes them
the first and only LDL-C lowering treatments indicated for primary
and secondary prevention of cardiovascular events.
The EC decisions follow the previous CHMP opinions
received in March this year, and approved bempedoic acid and its
fixed-dose combination (bempedoic acid / ezetimibe) for use 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.
In Europe, around one in seven people have high
LDL-C levels, and cardiovascular disease is the leading cause of
death, responsible for more than 10,000 lives lost every day.
However, up to 80% of patients do not reach guideline-recommended
LDL-C goals despite receiving treatments such as statins and are at
increased risk of a heart attack or stroke.
Bempedoic acid is a first-in-class oral treatment
which lowers cholesterol, and which can be combined with other
treatments to help lower cholesterol even further. Bempedoic acid
provided additional cholesterol lowering of up to 28% on top of
statin therapy, compared to placebo. Bempedoic acid / ezetimibe FDC
combines two complementary ways of reducing cholesterol in a
once-daily tablet, reduced LDL-C by 38% compared to placebo in
high-risk patients already taking maximum-tolerated statin
therapy.
“Today's announcement marks a pivotal moment in our
ongoing efforts to reduce cardiovascular risk. With the new
indication, which covers both primary and secondary prevention, we
can support healthcare professionals to better meet the treatment
needs in their daily practice. At the same time, we’re confident it
will reassure patients that their medication truly addresses their
CV risk. This reaffirms our commitment to be a trusted ally in
improving cardiovascular care throughout Europe,” said Oliver
Appelhans, Head of Europe Specialty Division, Daiichi Sankyo Europe
GmbH.
“We are delighted with the European Commission’s
approval, 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 further supports our efforts towards delivering
innovative treatment options to manage cardiovascular risk for
patients with elevated LDL-C.”
“Today’s positive label update reaffirms the
efficacy of both these treatments for reducing LDL-C levels and
ultimately reducing patients’ risk of serious cardiovascular
events,” said Professor Alberico Catapano, University of Milan,
Italy. “The announcement will provide doctors across Europe with
further confidence in prescribing bempedoic acid, alone or in
combination with ezetimibe, for managing the needs of their
patients.”
EC approval is based on results of the Phase 3
CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate
lyase (ACL)-Inhibiting Regimen) Outcomes trial. The trial
randomized a total of 13,970 patients aged 18–85 years old and was
conducted at 1,250 sites in 32 countries, including 485 sites
across Europe. 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 revascularization
(MACE-4).
- Results of the key secondary endpoints and subgroup analyses
have also been published.
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 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: |
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For
Esperion: |
For Daiichi
Sankyo Europe: |
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Investor Relations
Contact (Japan): |
investorrelations@esperion.com |
DaiichiSankyoIR@daiichisankyo.co.jp |
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Media: |
Dr. Wolfgang Schiessl
(Europe) |
Tiffany Aldrich |
wolfgang.schiessl@daiichi-sankyo.eu |
corporateteam@esperion.com |
+49 151 1714
7317 |
(616) 443-8438 |
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Sean Wood (Global /
US) |
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swood@webershandwick.com |
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+1 (212)
445-8310 |
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