Esperion (NASDAQ: ESPR) announced today that the U.S. Patent and
Trademark Office (USPTO) issued a U.S. Patent Term Extension (PTE)
certificate for bempedoic acid, which is contained in NEXLETOL®
(bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and
ezetimibe) Tablets. The certificate extends the term of U.S. Patent
No. 7,335,799 by five years through December 3, 2030. The PTE
certificate was granted under the patent restoration provisions of
the Drug Price Competition and Patent Term Restoration Act of 1984.
This PTE will be listed in Approved Drug Products with
Therapeutic Equivalence Evaluations (commonly known as the Orange
Book), published by the U.S. Food and Drug Administration
(FDA).
INDICATION NEXLIZET and NEXLETOL are
indicated:
- The bempedoic acid component of NEXLIZET and NEXLETOL is
indicated to reduce the risk of myocardial infarction and coronary
revascularization in adults who are unable to take recommended
statin therapy (including those not taking a statin) with:
- established cardiovascular disease (CVD), or
- at high risk for a CVD event but without established CVD.
- As an adjunct to diet:
- NEXLIZET, alone or in combination
with other LDL-C lowering therapies, to reduce LDL-C in adults with
primary hyperlipidemia, including HeFH.
- NEXLETOL, in combination with other LDL-C lowering therapies,
or alone when concomitant LDL-C lowering therapy is not possible,
to reduce LDL-C in adults with primary hyperlipidemia, including
HeFH.
IMPORTANT SAFETY INFORMATION NEXLIZET and
NEXLETOL are contraindicated in patients with a prior
hypersensitivity to bempedoic acid or ezetimibe or any of the
excipients. Serious hypersensitivity reactions including
anaphylaxis, angioedema, rash, and urticaria have been
reported.
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, returning to baseline following
discontinuation of treatment. 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 may occur more frequently in patients over
60 years of age, in those taking corticosteroid or fluoroquinolone
drugs, in patients with renal failure, and in patients with
previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the
first sign of tendon rupture. Consider alternative therapy in
patients who have a history of tendon disorders or tendon
rupture.
The most common adverse reactions in the primary hyperlipidemia
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 the primary hyperlipidemia trials of NEXLIZET, the most
commonly reported adverse reactions (incidence ≥3% and greater than
placebo) observed with NEXLIZET, but not observed in clinical
trials of bempedoic acid or ezetimibe, were urinary tract
infection, nasopharyngitis, and constipation.
The most common adverse reactions in the cardiovascular outcomes
trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at
an incidence of ≥2% and 0.5% greater than placebo were
hyperuricemia, renal impairment, anemia, elevated liver enzymes,
muscle spasms, gout, and cholelithiasis.
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 Esperion Therapeutics, Inc. Adverse Event
reporting line at 1-833-377-7633.
Please see full Prescribing Information for NEXLIZET and
NEXLETOL.
Esperion Therapeutics At 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. 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 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 and anticipated benefits
of legal proceedings and settlements, 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:
investorrelations@esperion.com
Media: Tiffany Aldrich corporateteam@esperion.com (616)
443-8438
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