Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and
Esperion Therapeutics (NASDAQ: ESPR) announced today Swissmedic
approval for NILEMDO®* (bempedoic acid) tablet and NUSTENDI®*
(bempedoic acid and ezetimibe) tablet, offering new treatment
options for people with high low-density lipoprotein cholesterol
(LDL-C) in Switzerland.
Bempedoic acid is the first oral, once-daily treatment option
approved in the last two decades for patients who have difficulty
reaching their cholesterol-lowering goals. In a recent
observational study, two-thirds of patients in Switzerland with
very high cardiovascular risk did not achieve LDL-C target values
set out by the European Society of Cardiology.3 Patients who do not
reach their LDL-C lowering goals are at increased risk for heart
attack and stroke.4 Diagnosis of high cholesterol has increased
among older adults in Switzerland in the past 20 years.5
“Cardiovascular disease remains a leading cause of death in
Switzerland. In 2017 it accounted for over 30% of deaths across the
country, highlighting a critical need for new treatment options for
the many people who are having difficulty reaching their LDL-C
goals with existing lipid-lowering therapies,” said Dr. Lucas
Schalch, Country Manager at Daiichi Sankyo Switzerland. “Today’s
approval of NILEMDO® and NUSTENDI® is a pivotal milestone for
patients in secondary prevention, offering them new, convenient
treatment options and demonstrating another step forward in our
commitment to reduce the risk of atherosclerotic cardiovascular
disease.”
“Bempedoic acid is a first-in-class adenosine
triphosphate-citrate lyase (ACL) inhibitor that lowers LDL-C by
inhibiting cholesterol synthesis in the liver. This unique
mechanism of action allows it to work alongside existing
treatments,” said Ashley Hall, Chief Development Officer of
Esperion. “Our focus is finding convenient, affordable ways for
appropriate patients to manage LDL-C. That is why we also developed
a single-tablet combination of bempedoic acid and ezetimibe, to
help reduce pill burden.”
Bempedoic acid and its fixed combination drug product with
ezetimibe were approved in the European Union and the United States
earlier this year with different labels and indications.1,6,7,8 In
Europe, the products are marketed as NILEMDO® and NUSTENDI®, and in
the U.S. as NEXLETOL® and NEXLIZET® (respectively).1,6,7,8 The
Esperion team discovered and developed bempedoic acid, drawing on
its deep expertise in developing cholesterol-lowering medicines.
With strong commercial capabilities, particularly in cardiovascular
medicine, Daiichi Sankyo has licensed exclusive commercialization
rights to bempedoic acid and the fixed combination drug product of
bempedoic acid and ezetimibe in the European Economic Area, Turkey
and Switzerland from Esperion. Marketing Authorization for both
products in Switzerland will be transferred to Daiichi Sankyo.
Swissmedic approved bempedoic acid for the treatment of adults
with clinically manifesting atherosclerotic cardiovascular disease
(ASCVD) or heterozygous familial hypercholesterolaemia (HeFH) who
need additional LDL-C lowering, as an adjunct to diet and in
combination with the maximum tolerated dose of a statin with or
without other lipid-lowering therapies.9 The fixed combination drug
product of bempedoic acid and ezetimibe is indicated as an adjunct
to diet in adults with clinically manifesting ASCVD or HeFH for
patients unable to reach LDL-C goals with the maximum tolerated
dose of a statin combined with ezetimibe or bempedoic acid, or
patients already being treated with the combination of bempedoic
acid and ezetimibe as separate tablets.10 Both approvals were
supported by data from the CLEAR trial program, which included more
than 3,600 high- and very-high-risk patients.9,10 The effect of
bempedoic acid on cardiovascular morbidity and mortality is
currently being investigated in 14,014 patients across 32 countries
as part of the CLEAR Outcomes study.11
Bempedoic acid was generally well-tolerated in clinical studies.
The most commonly reported adverse reactions with bempedoic acid
during pivotal trials were hyperuricaemia, pain in extremity and
anaemia. The majority of adverse reactions reported with bempedoic
acid were mild to moderate in severity and balanced in occurrence
with adverse events in patients receiving placebo.1,6-10
Daiichi SankyoDaiichi Sankyo Group is dedicated
to the creation and supply of innovative pharmaceutical therapies
to improve standards of care and address diversified, unmet medical
needs of people globally by leveraging our world-class science and
technology. With more than 100 years of scientific expertise and a
presence in more than 20 countries, Daiichi Sankyo and its 15,000
employees around the world draw upon a rich legacy of innovation
and a robust pipeline of promising new medicines to help people. In
addition to a strong portfolio of medicines for cardiovascular
diseases, under the Group’s 2025 Vision to become a “Global Pharma
Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo
is primarily focused on providing novel therapies in oncology, as
well as other research areas centred around rare diseases and
immune disorders. For more information, please visit:
www.daiichisankyo.com.
Esperion TherapeuticsThrough scientific and
clinical excellence, and a deep understanding of cholesterol
biology, the experienced Lipid Management Team at Esperion is
committed to developing new LDL-C lowering medicines that will make
a substantial impact on reducing global cardiovascular disease, the
leading cause of death around the world. 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 Esperion’s commercialization plans for
bempedoic acid tablet, its expectations for the market for
medicines to lower LDL-C and the impact of bempedoic acid tablet in
such market, including the commercial launch and the market
adoption of bempedoic acid tablet in the United States and European
Union. 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, delays or failures in Esperion’s clinical development
and commercialization plans, or approval of expanded indications,
that existing cash resources may be used more quickly than
anticipated, the impact of COVID-19 on our business, clinical
activities and commercial development 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.
References
* This medicinal product is subject to additional monitoring in
the European Union(1) European Medicines Agency. NILEMDO® Summary
of Product Characteristics. 27 Nov 2020:
https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf.
(2) Pinkosky SL, et al. Liver- specific ATP-citrate lyase
inhibition by bempedoic acid decreases LDL-C and attenuates
atherosclerosis. Nature Communications. 2016; 7:13457.
DOI:10.1038/ncomms13457.
(3) Rachamin Yael, et al. “Statin treatment and LDL target value
achievement in Swiss general practice – a retrospective
observational study,” 27 May 2020. Swiss Med Wkly. 2020;150:w20244:
https://smw.ch/article/doi/smw.2020.20244
(4) WHO. Cardiovascular diseases (CVDs) Factsheet. 2017.
Available online at:
https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).
Last accessed December 2020.
(5) Swiss Federation Federal Statistical Office report,
Gesundheitsstatistik 2019, 29 Oct 2019:
https://www.bfs.admin.ch/bfsstatic/dam/assets/10227275/master;
(6) European Medicines Agency. NUSTENDI® Summary of Product
Characteristics. 27 Nov 2020:
https://www.ema.europa.eu/en/documents/product-information/nustendi-epar-product-information_en.pdf.
(7) U.S. Food and Drug Administration. NEXLETOL® Prescribing
Information. 27 Nov 2020:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211616s000lbl.pdf.
(8) U.S. Food and Drug Administration. NEXLIZET® Prescribing
Information. 27 Nov 2020:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211617s000lbl.pdf.
(9) Swissmedic. NILEMDO® (bempedoic acid) Product Information
for Human Medicinal Products. December 2020.
(10) Swissmedic. NUSTENDI® (bempedoic acid and ezetimibe)
Product Information for Human Medicinal Products. December
2020.
(11) Stephen J Nicholls et al, Rationale and design of the
CLEAR-outcomes trial: Evaluating the effect of Bempedoic acid on
cardiovascular events in patients with statin intolerance, American
Heart Journal (2020), https://doi.org/10.1016/j.ahj.2020.10.060
Contacts:Daiichi Sankyo Europe GmbHDr. Wolfgang
Schiessl (Europe)Director Product PR and Communications,
Cardiovascular Europe+49 151 1714 7317
Esperion corporateteam@esperion.com
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