Esperion (NASDAQ: ESPR) announced today that NEXLIZETTM (bempedoic
acid and ezetimibe) tablets, the first approved oral, once-daily,
non-statin LDL-Cholesterol (LDL-C) lowering combination medicine is
now available in U.S. pharmacies. NEXLIZET provides
significant efficacy with a positive risk-benefit profile and
requires minimal to no paperwork for health care providers (HCPs)
during this incredibly demanding and unprecedented time when
patients start to re-focus on their long-term health needs and
underlying conditions. Additionally, NEXLIZET is introduced
with broad payer coverage for both eligible insured patients and
those with Medicare Part D at an affordable price and co-pay.
As the first non-statin LDL-C lowering fixed dose combination
medicine ever approved by the FDA, NEXLIZET offers healthcare
providers the opportunity to simultaneously use complementary
medicines in a single oral tablet with no titration. NEXLIZET
is indicated as an adjunct to diet and maximally tolerated statin
therapy for the treatment of adults with heterozygous familial
hypercholesterolemia (HeFH) or established atherosclerotic
cardiovascular disease (ASCVD) who require additional lowering of
LDL-C. The effect of NEXLIZET on cardiovascular morbidity and
mortality has not been determined. NEXLIZET lowered LDL-C by
a mean of 38 percent compared to placebo when added on to maximally
tolerated statins. Results have been published in The European
Journal of Preventive Cardiology.
“I am excited to have a newly approved statin add-on combination
medicine. “NEXLIZET offers substantial LDL-lowering efficacy with a
positive risk-benefit profile. It is a single pill with a single
co-pay and is indicated for patients struggling to reach their
cholesterol goals despite diet plus maximally-tolerated statin
therapy,” said Eliot A. Brinton, MD, FAHA, FNLA, FACE,
President of the Utah Lipid Center, past-President of the American
Board of Clinical Lipidology and advisor to Esperion. “I
anticipate that NEXLIZET will become a go-to option after statins
because it provides double the LDL-C lowering efficacy of
ezetimibe, without the need for titration. It also has
favorable safety and excellent access at a low cost for
patients.”
“More than ever, health care providers are seeking more options
to help the millions of patients reach their cholesterol goals and
address their long-term health needs,” said Mark Glickman, chief
commercial officer of Esperion. “NEXLIZET is highly anticipated, so
we are responding by accelerating its commercial
availability. HCPs can easily prescribe NEXLIZET because it
does not require any extra paperwork or injection training,
potentially limiting the need for additional human contact during
these unique times.”
NEXLIZET is the second commercially available product from
Esperion. The company introduced NEXLETOLTM (bempedoic acid)
Tablets on March 30, 2020 at the height of the Covid-19 pandemic
and was the first new oral, once daily non-statin medicine approved
in nearly 20 years for indicated patients. Esperion is
committed to providing oral, once-daily non-statin LDL-C lowering
treatment options that are affordable and accessible. Eligible
patients with commercial drug insurance coverage may pay as little
as $10 per fill, up to a 3-month supply. For those that need
NEXLIZET or NEXLETOL, Esperion’s mission is to considerably reduce
cost as a burden for patients as they strive to achieve their
long-term LDL-C goals.
There are several ways to learn about NEXLIZET based on your
preference. Healthcare providers with questions regarding NEXLIZET
can call 833-377-7633 (833 ESPRMED) and select OPTION 1 where our
medical information team is available from Monday-Friday (except
holidays) 8:00 a.m. to 8:00 p.m. Eastern Time to assist
you. If preferred, you can submit your questions by email via
medinfo@esperion.com. If interested in speaking with a sales
representative from Esperion please call 833-377-7633 (833 ESPRMED)
and select OPTION 2. Press OPTION 3 for Copay questions. Visit
www.esperion.com for general information about our company.
NEXLIZETTM (bempedoic acid and ezetimibe)
Tablets
NEXLIZET contains bempedoic acid and ezetimibe and lowers
elevated LDL-C through complementary mechanisms of action by
inhibiting cholesterol synthesis in the liver and absorption in the
intestine. Phase 3 data demonstrated NEXLIZET lowered LDL-C by a
mean of 38 percent compared to placebo when added on to maximally
tolerated statins. NEXLIZET is the first non-statin,
LDL-cholesterol lowering combination medicine ever approved.
NEXLIZET was approved by the FDA in February 2020.
Indication and Limitation of Use NEXLIZET 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
NEXLIZET on cardiovascular morbidity and mortality has not been
determined.
Important Safety Information
- Contraindications:
- Known hypersensitivity to ezetimibe tablets.
- 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
NEXLIZET was higher in patients with a prior history of gout
although gout also occurred more frequently than placebo in
patients treated with NEXLIZET who had no prior gout history.
- Tendon rupture has occurred. Discontinue NEXLIZET at the first
sign of tendon rupture. Avoid NEXLIZET in patients who have a
history of tendon disorders or tendon rupture.
- Adverse Reactions:
- The most common adverse events reported in the development
program (incidence ≥ 2% and greater than placebo) were upper
respiratory tract infection, muscle spasms, hyperuricemia, back
pain, abdominal pain or discomfort, bronchitis, pain in extremity,
anemia, elevated liver enzymes, diarrhea, arthralgia, sinusitis
fatigue, and influenza.
- Drug Interactions:
- Simvastatin: Avoid concomitant use of NEXLIZET with
simvastatin great than 20 mg
- Pravastatin: Avoid concomitant use of NEXLIZET with pravastatin
greater than 40 mg.
- Cyclosporine: Monitor cyclosporine concentrations in
patients receiving NEXLIZET and cyclosporine.
- Fibrates: If cholelithiasis is suspected in a patient
receiving NEXLIZET and fenofibrate, consider alternative
lipid-lowering therapy.
- Use in Specific Populations
- Pregnancy: Based on mechanism of action, may cause fetal
harm.
- Lactation: Breastfeeding is not recommended with NEXLIZET.
Click here to see the full prescribing
information for NEXLIZET™ (bempedoic acid and
ezetimibe) tablet.
Patients or their physicians 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).
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. Completed Phase 3 studies
conducted in more than 3,000 patients, with over 2,000 patients
treated with NEXLETOL, demonstrated an average 18 percent placebo
corrected LDL-C lowering when used in patients on moderate or
high-intensity statins. 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.
CLEAR Cardiovascular Outcomes
Trial
The effect of NEXLETOL or NEXLIZET on cardiovascular morbidity
and mortality has not been determined. Esperion initiated a global
cardiovascular outcomes trial (CVOT) to assess the effects of
bempedoic acid on the occurrence of major cardiovascular events in
patients with, or at high risk for, cardiovascular disease (CVD)
who are only able to tolerate less than the lowest approved daily
starting dose of a statin and are considered "statin averse." The
CVOT — known as CLEAR Cardiovascular Outcomes Trial — is an
event-driven, global, randomized, double-blind, placebo-controlled
study that completed enrollment in August 2019 of 14,032 patients
with hypercholesterolemia and high CVD risk at over 1,400 sites in
32 countries.
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 ASCVD patients who are not able to reach
their LDL-C with statins alone need less than a 40 percent
reduction to reach their LDL-C threshold2.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 and other ongoing
clinical studies for bempedoic acid tablet and the bempedoic acid /
ezetimibe combination fixed dose tablet, 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, 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.
Investor Contact: Alex Schwartz Esperion
734-249-3386 aschwartz@esperion.com
Media Contact: Ben
ChurchEsperion734-864-6774bchurch@esperion.com
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