Esperion (NASDAQ: ESPR) today announced results of pooled data from
four of the company’s Phase 3 trials were presented at the virtual
American Heart Association Scientific Sessions 2020 (AHA 2020).
Both analyses demonstrated significant lowering of low-density
lipoprotein cholesterol (LDL-C) by NEXLETOL® (bempedoic acid)
Tablets by week 12 in specific subgroups, including people who
cannot tolerate statins and females, compared to
placebo.
“Women are half of the population, and nearly 10 million
patients in the U.S. with high LDL-C levels are not on statins due
to tolerability issues,3 yet these groups have been
underrepresented in previous medical research,4” said Ashley Hall,
Chief Development Officer for Esperion. “Our goal at Esperion is
lipid management for everybody, and these analyses show significant
LDL-C efficacy and acceptable safety for NEXLETOL in these
subgroups.”
In “Efficacy and Safety of Bempedoic Acid in Patients Who Cannot
Tolerate Any Dose of a Statin: Pooled Analysis from Phase 3
Clinical Trials,” (Abstract #P2139) data from a subgroup of more
than 580 patients not receiving any dose of a statin showed a
significant mean reduction of 26.5% (p< 0.001) in LDL-C by week
12 with NEXLETOL vs. placebo. NEXLETOL was generally well
tolerated, with treatment-emergent adverse events (TEAEs)
comparable across the bempedoic acid and placebo groups.1
The poster “Efficacy and Safety of Bempedoic Acid by Sex: Pooled
Analyses From Phase 3 Trials” (Abstract #P742) showed NEXLETOL
significantly lowered LDL-C at week 12 in both sexes compared with
placebo for a pooled population of more than 3,600 patients across
four studies. LDL-C lowering was numerically greater in females
compared with males across both pools of the study: The
placebo-corrected mean reduction was 27.7% for females vs. 22.1%
for males (interaction p value=0.079) in the statin-intolerant
pool, and 21.2% for females vs. 17.4% for males (interaction p
value=0.044) in the pool of patients with atherosclerotic
cardiovascular disease (ASVCD) and/or heterozygous familial
hypercholesterolemia (HeFH) who were receiving background maximally
tolerated statin. Bempedoic acid was generally well tolerated by
both sexes.2
Approved earlier this year by the U.S. Food and Drug
Administration (FDA) and launched at the height of the COVID-19
pandemic, NEXLETOL is the first oral, once-daily, non-statin
LDL-C-lowering medicine available to indicated patients in nearly
20 years. The approval of NEXLETOL was supported by a global
pivotal Phase 3 LDL-C-lowering program conducted in more than 3,000
patients with ASCVD and/or HeFH. In these studies, NEXLETOL
provided an average of 18% placebo-corrected LDL-C lowering when
used with moderate or high-intensity statins. The most common
(incidence ≥ 2% and greater than placebo) 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. NEXLETOL is indicated
as an adjunct to diet and maximally tolerated statin therapy for
the treatment of adults with HeFH or established ASCVD who require
additional lowering of LDL-C. The effect of NEXLETOL on
cardiovascular morbidity and mortality has not yet been determined.
Please see important safety information below.
*Note: Esperion strives to be inclusive in our both research and
our language, and we follow the language guidance outlined in
“Reporting Sex, Gender, or Both in Clinical Research?” from The
Journal of the American Medicine Association (JAMA).
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:
- 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.
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 commercialization plans for bempedoic acid
tablet. 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.
References1 Laufs U, et al. Efficacy and Safety
of Bempedoic Acid in Patients who Cannot Tolerate Any Does of a
Statin: Pooled Analysis from Phase 3 Clinical Trials. Presentation
at the American Heart Association Virtual Scientific Sessions 2020.
November 2020.
2 Goldberg AC, et al. Efficacy and Safety of Bempedoic Acid by
Sex: Pooled Analyses From Phase 3 Trials. Presentation at the
American Heart Association Virtual Scientific Sessions 2020.
November 2020.
3 ZS Associates primary and secondary research, Sep-Oct 2018.
Primary research N = 350 healthcare practitioners
4 J Tamargo, G Rosano, T Walther, J Duarte, A Niessner, JC
Kaski, C Ceconi, H Drexel, K Kjeldsen, G Savarese, C Torp-Pedersen,
D Atar, BS Lewis, S Agewall, Gender differences in the effects of
cardiovascular drugs, European Heart Journal - Cardiovascular
Pharmacotherapy, Volume 3, Issue 3, July 2017, Pages 163–182,
https://doi.org/10.1093/ehjcvp/pvw042
Contact:Kaitlyn Brosco
Esperioninvestorrelations@esperion.com
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