Esperion (NASDAQ: ESPR) announced today that the U.S. Food and Drug
Administration (FDA) has approved an updated LDL-cholesterol
lowering indication for NEXLETOL and NEXLIZET to include the
treatment of primary hyperlipidemia as a qualifier for existing
approved populations. Additionally, the maximally tolerated
qualifier for statin use has been removed, and the prior limitation
of use stating “the effect of NEXLIZET or NEXLETOL on
cardiovascular morbidity and mortality has not been determined” has
also been removed.
This update is effective immediately and is the result of the
FDA’s efforts to modernize and synchronize drug labels, as well as
Esperion’s commitment to expanding the indications for NEXLETOL and
NEXLIZET. “We are pleased that the FDA has approved these
modifications to our current indications for NEXLETOL and NEXLIZET,
which reinforce the proven efficacy and safety of these
treatments,” said Sheldon Koenig, President and CEO.
These labeling modifications do not impact the full pending
label approvals for cardiovascular risk reduction indications for
NEXLETOL and NEXLIZET, which remain on track for anticipated
approval in the first quarter of 2024. In June 2023, the Company
announced its submission of four Supplemental New Drug Applications
based on the landmark Cholesterol Lowering via Bempedoic acid, an
ACL-Inhibiting Regimen (CLEAR) Outcomes trial, which demonstrated
that bempedoic acid, contained in both NEXLETOL and NEXLIZET, can
significantly reduce cardiovascular risk across a range of primary
and second endpoints. These applications were accepted by the FDA
which issued a PDUFA, or action, date of March 31, 2024. The
Company’s EMA applications also remain on track, with anticipated
approval in the first half of 2024.
INDICATIONNEXLETOL /NEXLIZET is indicated as an
adjunct to diet and statin therapy for the treatment of primary
hyperlipidemia in adults with heterozygous familial
hypercholesterolemia (HeFH) or atherosclerotic cardiovascular
disease, who require additional lowering of LDL-C.
IMPORTANT SAFETY INFORMATIONNEXLIZET is
contraindicated in patients with a known hypersensitivity to
ezetimibe tablets. Hypersensitivity reactions including
anaphylaxis, angioedema, rash, and urticaria have been reported
with ezetimibe, a component of NEXLIZET.
Hyperuricemia: Bempedoic acid, a component of NEXLIZET and
NEXLETOL, may increase blood uric acid levels which may lead to
gout. 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: Bempedoic acid, a component of NEXLIZET and
NEXLETOL, is associated with an increased risk of tendon rupture or
injury. Tendon rupture occurred within weeks to months of starting
NEXLIZET or 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 NEXLIZET or NEXLETOL at
the first sign of tendon rupture. Avoid NEXLIZET or NEXLETOL in
patients who have a history of tendon disorders or tendon
rupture.
The most common adverse reactions in clinical trials of
bempedoic acid (a component of NEXLIZET and NEXLETOL) in ≥2% of
patients and greater than placebo, were upper respiratory tract
infection, muscle spasms, hyperuricemia, back pain, abdominal pain
or discomfort, bronchitis, pain in extremity, anemia, and elevated
liver enzymes.
Adverse reactions reported in ≥2% of patients treated with
ezetimibe (a component of NEXLIZET) and at an incidence greater
than placebo in clinical trials were upper respiratory tract
infection, diarrhea, arthralgia, sinusitis, pain in extremity
fatigue, and influenza.
In clinical trials of NEXLIZET, the most commonly reported
adverse reactions (incidence ≥3% and greater than placebo) observed
that not observed in clinical trials of bempedoic acid or
ezetimibe, were urinary tract infection, nasopharyngitis, and
constipation.
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized
unless the benefits of therapy outweigh the potential risks to the
fetus. Because of the potential for serious adverse reactions in a
breast-fed infant, breastfeeding is not recommended during
treatment with NEXLIZET or NEXLETOL. Report pregnancies to the
Esperion Therapeutics, Inc. Adverse Event reporting line at
1-833-377-7633.
Esperion TherapeuticsAt Esperion, we discover,
develop, and commercialize innovative medicines to help improve
outcomes for patients with or at risk for cardiovascular and
cardiometabolic diseases. The status quo is not meeting the health
needs of millions of people with high cholesterol – that is why our
team of passionate industry leaders is breaking through the
barriers that prevent patients from reaching their goals. Providers
are moving toward reducing LDL-cholesterol levels as low as
possible, as soon as possible; we provide the next steps to help
get patients there. Because when it comes to high cholesterol,
getting to goal is not optional. It is our life’s work. For more
information, visit esperion.com and esperionscience.com and follow
us on X at twitter.com/EsperionInc.
CLEAR Cardiovascular Outcomes TrialCLEAR
Outcomes is part of the CLEAR clinical research program for
NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and
ezetimibe) Tablet. The CLEAR Program seeks to generate important
clinical evidence on the safety and efficacy of bempedoic acid, a
first in a class ATP citrate lyase inhibitor contained in NEXLETOL
and NEXLIZET and its potential role in addressing additional
critical unmet medical needs. More than 60,000 people will have
participated in the program by the time of its completion. The
CLEAR Program includes 5 label-enabling Phase III studies as well
as other key Phase IV studies with the potential to reach more than
70 million people with or at risk for CVD based on elevated
LDL-C.
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 net sales,
profitability, and growth of Esperion’s commercial products,
clinical activities and results, supply chain, commercial
development and launch plans, the outcomes of legal proceedings,
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.
Esperion Contact Information:Investors: Alexis
Callahaninvestorrelations@esperion.com (406) 539-1762
Media: Tiffany Aldrich corporateteam@esperion.com (616)
443-8438
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