Esperion (NASDAQ: ESPR) today announced that bempedoic acid
(NEXLETOL®) is now recommended as an important oral non-statin
therapy for LDL-cholesterol (LDL-C) lowering in the management of
atherosclerotic cardiovascular disease (ASCVD) by the American
College of Cardiology (ACC) task force on expert consensus decision
pathways (ECDP). The recommendation, an update to the 2017 ECDP,
was released on August 25, 2022 and published online in the Journal
of the American College of Cardiology.
“The recommendation of bempedoic acid for LDL-C lowering in
individuals at high-risk for ASCVD reflects an important management
strategy for providers and the millions of patients who cannot
reach their LDL-C goals with a statin alone,” said JoAnne Foody,
MD, FACC, FAHA, Chief Medical Officer of Esperion. “LDL-C is
causative in development of atherosclerotic CV disease and residual
CV risk remains high if LDL-C remains elevated despite statins.
While studies show reducing LDL-C levels with lipid-lowering agents
lowers incidence of ASCVD events, most patients still do not reach
their LDL-C goal. There is urgent need for the use of non-statin
lipid-lowering therapies in appropriate patients to reduce LDL-C.
The ACC ECDP recommendation underscores the importance of LDL-C
lowering via multiple therapeutic options including oral therapies
like bempedoic acid and ezetimibe and provides important guidance
for the management of patients not served by current statin
therapies.”
“These guidelines will be helpful for providers and payers to
understand the value of non-statin therapies in helping patients
achieve LDL-C goals,” said BJ Swartz, Chief Strategy Officer of
Esperion. “They provide clear guidance on how new and existing
non-statin adjunctive therapies will contribute to LDL-C goal
attainment and have the potential to reduce cardiovascular risk in
their patient populations.”
The 2022 ACC Expert Consensus statement seeks to address current
gaps in care for LDL-C lowering to reduce ASCVD risk and provides
recommendations for clinicians and patients regarding the use of
non-statin therapies in high-risk patients who have a minimal
response to statins or are statin intolerant. The recommendation of
bempedoic acid, the first oral, once-daily, non-statin LDL-C
lowering medicine approved since 2002, is based on robust Phase III
clinical trial evidence including evidence from the CLEAR
Tranquility (Evaluation of the Efficacy and Safety of Bempedoic
Acid [ETC-1002] as Add-on to Ezetimibe Therapy in Patients With
Elevated LDL-C) and CLEAR Serenity (Evaluation of the Efficacy and
Safety of Bempedoic Acid in Patients With Hyperlipidemia and Statin
Intolerant) trials, which demonstrated that monotherapy with
bempedoic acid 180 mg daily in patients with statin-associated
muscle symptoms on no statin therapy reduced LDL-C levels by
approximately 24.5% compared with placebo.
In addition to the ACC ECDP, the American Association of
Clinical Endocrinologists (AACE) and the American College of
Endocrinology (ACE) recommend bempedoic acid for treating LDL-C to
goal in their Dyslipidemia and Prevention of Cardiovascular Disease
Algorithm. The potential ability of bempedoic acid to reduce
cardiovascular risk in patients with statin-intolerance is
currently being evaluated in a global cardiovascular outcomes trial
(CVOT), known as CLEAR Outcomes. The Company anticipates top-line
results from the trial in the first quarter of 2023.
CLEAR Cardiovascular Outcomes TrialThe effect
of bempedoic acid 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. 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 over 14,000 patients with hypercholesterolemia and high CVD risk
at over 1,200 sites in 32 countries.
INDICATION 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. Limitations of Use: The effect of
NEXLETOL on cardiovascular morbidity and mortality has not been
determined.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions: Hyperuricemia:
NEXLETOL may increase blood uric acid levels. 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: NEXLETOL is associated with an
increased risk of tendon rupture or injury. In clinical trials,
tendon rupture occurred in 0.5% of patients treated with NEXLETOL
versus 0% of patients treated with placebo, and involved the
rotator cuff (the shoulder), biceps tendon, or Achilles tendon.
Tendon rupture occurred within weeks to months of starting
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 NEXLETOL at the first sign of tendon
rupture. Avoid NEXLETOL in patients who have a history of tendon
disorders or tendon rupture.
Adverse Reactions: In clinical trials, the most
commonly reported adverse reactions were upper respiratory tract
infection, muscle spasms, hyperuricemia, back pain, abdominal pain
or discomfort, bronchitis, pain in extremity, anemia, and elevated
liver enzymes. Reactions reported less frequently, but still more
often than with placebo, included benign prostatic hyperplasia and
atrial fibrillation.
Drug Interactions: Simvastatin and Pravastatin:
Concomitant use results in increased concentrations and increased
risk of simvastatin or pravastatin-related myopathy. Use with
greater than 20 mg of simvastatin or 40 mg of pravastatin should be
avoided.
Lactation and Pregnancy: It is not recommended
that NEXLETOL be taken during breastfeeding. Discontinue NEXLETOL
when pregnancy is recognized, unless the benefits of therapy
outweigh the potential risks to the fetus. Based on the mechanism
of action, NEXLETOL may cause fetal harm.
Please see full Prescribing Information here.
Esperion TherapeuticsEsperion works hard to
make our medicines easy to get, easy to take and easy to have. We
discover, develop, and commercialize innovative medicines and
combinations to lower cholesterol, especially for patients whose
needs are not being met by the status quo. Our entrepreneurial team
of industry leaders is inclusive, passionate and resourceful. We
are singularly focused on managing cholesterol so you can improve
your health easily. Esperion commercializes NEXLETOL® (bempedoic
acid) and NEXLIZET® (bempedoic acid and ezetimibe) Tablets and is
the leader in the development of convenient oral, once-daily
non-statin LDL-cholesterol lowering drugs for patients with high
levels of bad cholesterol. 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 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 impact of the ongoing
COVID-19 pandemic on our business, revenues, results of operations
and financial condition, the net sales, profitability, and growth
of Esperion’s commercial products, clinical activities and results,
supply chain, commercial development and launch 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.
Contact:Esperion Corporate
Communicationscorporateteam@esperion.com
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