Esperion Announces Two Data Presentations of NEXLETOL® (bempedoic acid) Tablet at the ESC Congress 2020
August 26 2020 - 9:07AM
Esperion (NASDAQ:ESPR) today announced that it will present a
pooled analysis from four Phase 3 clinical trials of NEXLETOL®
(bempedoic acid) tablets as well as long-term safety and efficacy
data from the CLEAR Harmony open-label extension study of NEXLETOL
at the ESC Congress 2020, the annual meeting of the European
Society of Cardiology, being held virtually from August 29th –
September 1st, 2020.
Details of the poster presentations are as follows:
Title: Effect of bempedoic acid on uric acid
and gout in 3621 patients with hypercholesterolemia: pooled
analyses from phase 3 trials Presenting Author:
Kausik K Ray, MBChB, MD, MPhil Session: Risk
Factors and Prevention ePosters
Title: Long-term safety and efficacy of
bempedoic acid in patients at high risk of atherosclerotic
cardiovascular disease: results from the CLEAR Harmony open-label
extension study Presenting Author: Christie
Ballantyne, MD Session: Pharmacology and
Pharmacotherapy ePosters
Both presentations will be available as on-demand ePoster
presentations beginning Friday, August 28, 2020.
NEXLETOL was approved by the U.S. Federal Drug Administration
(FDA) on February 21, 2020 and by the European Commission on April
6, 2020 under the name NILEMDO™ (bempedoic acid). Daiichi Sankyo
Europe has licensed exclusive commercialization rights to NILEMDO
in the European Economic Area, Switzerland and Turkey from
Esperion. It is expected to be commercially available in Europe in
the fourth quarter of 2020.
NEXLETOL® (bempedoic acid)
Tablet
NEXLETOL is a first-in-class ATP Citrate Lyase (ACL) inhibitor
that lowers LDL-C by reducing cholesterol biosynthesis and
up-regulating the LDL receptors. NEXLETOL is the first oral,
once-daily, non-statin LDL-C lowering medicine approved in the U.S.
in nearly 20 years for patients with ASCVD or HeFH. NEXLETOL was
approved by the FDA in February 2020.
Indication and Limitation of Use NEXLETOL is indicated as an
adjunct 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. The effect of NEXLETOL on
cardiovascular morbidity and mortality has not been determined.
Important Safety Information
- Warnings and Precautions:
-
- Elevations in serum uric acid have occurred. Assess uric acid
levels periodically as clinically indicated. Monitor for signs and
symptoms of hyperuricemia, and initiate treatment with
urate-lowering drugs as appropriate. The risk for gout events with
NEXLETOL™ (bempedoic acid) tablet was higher in patients with a
prior history of gout although gout also occurred more frequently
than placebo in patients treated with NEXLETOL™ (bempedoic acid)
tablet who had no prior gout history.
- Tendon rupture has occurred. Discontinue NEXLETOL™ (bempedoic
acid) tablet at the first sign of tendon rupture. Avoid NEXLETOL™
(bempedoic acid) tablet in patients who have a history of tendon
disorders or tendon rupture.
- Adverse Reactions:
- The most common (incidence ≥ 2% and greater than placebo)
adverse reactions are upper respiratory tract infection, muscle
spasms, hyperuricemia, back pain, abdominal pain or discomfort,
bronchitis, pain in extremity, anemia and elevated liver
enzymes.
- Drug Interactions:
- Avoid concomitant use of NEXLETOL with simvastatin greater than
20 mg.
- Avoid concomitant use of NEXLETOL with pravastatin greater than
40 mg.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088 or report side effects to Esperion at
833-377-7633 (833 ESPRMED).
Please see the full Prescribing Information for NEXLETOL by
clicking here.
Esperion Therapeutics
Through 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.
Esperion Therapeutics’ Commitment to Patients with
Hyperlipidemia
High levels of LDL-C can lead to a build-up of fat and
cholesterol in and on artery walls (known as atherosclerosis),
potentially leading to cardiovascular events, including heart
attack and stroke. In the U.S., 96 million people, or more than 37
percent of the adult population, have elevated LDL-C. There are
approximately 18 million people in the U.S. living with elevated
levels of LDL-C despite taking maximally tolerated lipid-modifying
therapy — including individuals considered statin averse — leaving
them at high risk for cardiovascular events1. In the United States,
more than 50 percent of atherosclerotic cardiovascular disease
(ASCVD) patients and heterozygous familial hypercholesterolemia
(HeFH) patients who are not able to reach their guideline
recommended LDL-C levels with statins alone need less than a 40
percent reduction to reach their LDL-C threshold goal2.
Esperion's mission as the Lipid Management Company is to deliver
oral, once-daily medicines that complement existing oral drugs to
provide the additional LDL-C lowering that these patients need.
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 the clinical
development and commercialization plans for bempedoic acid tablet
and the bempedoic acid / ezetimibe fixed dose combination tablet,
including Esperion's timing, designs, plans for announcement of
results regarding its CLEAR Outcomes study, timing for the review
and approval of expanded indications for their effect on
cardiovascular events, and Esperion's expectations for the market
for medicines to lower LDL-C, including the commercial launch and
market adoption of bempedoic acid tablet and the bempedoic acid /
ezetimibe fixed dose combination 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, that Otsuka is able to successfully commercialize
bempedoic acid and the bempedoic acid / ezetimibe fixed dose
combination tablet, 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(1) Esperion market research on
file: research project interviewing 350 physicians. Esperion
Therapeutics, Inc. Sept-Oct 2018.(2) Data on file: analysis
of NHANES database. Esperion Therapeutics, Inc. 2018.
Contact: Ben Church Esperion734-864-6774bchurch@esperion.com
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