THOUSAND OAKS, Calif.,
April 15, 2015 /PRNewswire/
-- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and
Drug Administration (FDA) has granted approval of
Corlanor® (ivabradine), an oral medication indicated to
reduce the risk of hospitalization for worsening heart failure in
patients with stable, symptomatic chronic heart failure with left
ventricular ejection fraction (LVEF) ≤35 percent, who are in sinus
rhythm with resting heart rate ≥70 beats per minute (bpm) and
either are on maximally tolerated doses of beta blockers or have a
contraindication to beta blocker use.
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Heart failure is a common condition that affects approximately
5.7 million people in the U.S., about half of which have reduced
left ventricular function.1,2 Despite broad use of
standard treatments, the prognosis for patients with heart failure
is poor.3 Projections show that by 2030, the prevalence
of heart failure will increase 46 percent from 2012
estimates.1
"We are excited to introduce Corlanor, the first new chronic
heart failure medicine approved by the FDA in nearly a decade, for
patients who are at a significantly greater risk of hospitalization
due to worsening heart failure in the U.S.," said Sean E.
Harper, M.D., executive vice president of Research and Development
at Amgen. "Many heart failure patients are repeatedly admitted
to the hospital, which can cause a great burden on the patient and
on healthcare resources. We hope that today's approval of Corlanor
as an innovative therapeutic option will address a major unmet need
for patients, their families and the healthcare system."
Heart failure costs an estimated $31
billion in the U.S. each year, with the majority of the cost
related to hospitalizations.4 By 2030, the cost of heart
failure in the U.S. is expected to increase almost 127 percent
totaling $70 billion.4
"The approval of Corlanor is an important step forward for the
treatment of patients with chronic heart failure in the U.S.
Because its mechanism of action is unique, it will complement the
use of standard heart failure therapies, including beta blockers,"
said Jeffrey S. Borer, M.D.,
professor of Medicine, Cell Biology, Radiology and Surgery, and
chief of Cardiovascular Medicine at State
University of New York, Downstate Medical Center. "Despite
beta blockade and other therapies, many people with chronic heart
failure continue to suffer hospitalizations due to worsening heart
failure. For these patients, when heart rate is greater than or
equal to 70 bpm, Corlanor may be an appropriate treatment option
and can be expected to add benefit."
Corlanor blocks the hyperpolarization-activated cyclic
nucleotide-gated (HCN) channel responsible for the cardiac
pacemaker, which regulates heart rate. Corlanor reduces the
spontaneous pacemaker activity of the cardiac sinus node by
selectively inhibiting the If current ("funny"
current) to slow the heart rate with no effect on ventricular
repolarization and no effects on myocardial
contractility.5
The Corlanor approval is based on global clinical trial data
including a large, multicenter, randomized, double-blind,
placebo-controlled, outcomes trial. The Phase 3 SHIFT (Systolic
Heart failure treatment with the If inhibitor
ivabradine Trial) study compared Corlanor to placebo on top of
standard of care (SOC) therapies, including beta blockers, in more
than 6,500 clinically stable (≥4 weeks) patients in sinus rhythm
with reduced left ventricular function (LVEF ≤35 percent) and heart
rate ≥70 bpm, with a hospitalization for heart failure within the
past 12 months. Patients received SOC, including beta blockers (89
percent), angiotensin converting enzyme (ACE) inhibitors and/or
angiotensin II receptor blockers (ARB) (91 percent), diuretics (83
percent) and anti-aldosterone agents (60 percent).
Results from the Phase 3 SHIFT study showed Corlanor
significantly reduced the risk of the primary composite endpoint of
hospitalization or cardiovascular death for worsening heart
failure, with 18 percent relative risk reduction (RRR)
(p<0.0001, 4.2 percent absolute risk reduction [ARR])
versus placebo. The treatment effect reflected only a reduction in
the risk of hospitalization for worsening heart failure; there was
no favorable effect on the mortality component of the primary
endpoint. There was a 26 percent RRR (4.7 percent ARR) in the risk
of hospitalizations for worsening heart failure.
The most common adverse drug reactions in the SHIFT study
occurring in ≥1 percent of patients on Corlanor compared to placebo
were bradycardia (10 percent vs. 2.2 percent), hypertension or
increased blood pressure (8.9 percent vs. 7.8 percent), atrial
fibrillation (8.3 percent vs. 6.6 percent), and luminous phenomena
(phosphenes) or visual brightness (2.8 percent vs. 0.5
percent).
The recommended starting dose of Corlanor is a 5 mg tablet twice
daily with meals. After two weeks of treatment, the dose should be
assessed and adjusted depending on heart rate. In patients with a
history of conduction defects, or other patients in whom
bradycardia could lead to hemodynamic compromise, initiate therapy
at 2.5 mg twice daily before increasing the dose based on heart
rate.
Corlanor is expected to be available to patients in
approximately one week.
About
Corlanor® (ivabradine)
Corlanor blocks the hyperpolarization-activated cyclic
nucleotide-gated (HCN) channel responsible for the cardiac
pacemaker, which regulates heart rate. Corlanor reduces the
spontaneous pacemaker activity of the cardiac sinus node by
selectively inhibiting the If current ("funny"
current) to slow the heart rate with no effect on ventricular
repolarization and no effects on myocardial
contractility.5 Corlanor was developed by Les
Laboratoires Servier. Through a collaboration with Servier, Amgen
has rights to commercialize Corlanor in the U.S.
Important U.S. Product
Information
Corlanor® is indicated to reduce the risk of
hospitalization for worsening heart failure in patients with
stable, symptomatic chronic heart failure with left ventricular
ejection fraction ≤ 35%, who are in sinus rhythm with resting heart
rate ≥ 70 beats per minute (bpm) and either are on maximally
tolerated doses of beta blockers or have a contraindication to beta
blocker use.
Important Safety
Information
- Contraindications: Corlanor® is
contraindicated in patients with acute decompensated heart failure,
blood pressure < 90/50 mmHg, sick sinus syndrome, sinoatrial
block, 3rd degree AV block (unless a functioning demand
pacemaker is present), a resting heart rate < 60 bpm prior to
treatment, severe hepatic impairment, pacemaker dependence (heart
rate imposed exclusively by the pacemaker) and concomitant use of
strong cytochrome P450 3A4 (CYP3A4) inhibitors.
- Fetal Toxicity: Corlanor® may cause fetal
toxicity when administered to a pregnant woman.
- Atrial Fibrillation: Corlanor® increases the
risk of atrial fibrillation. The rate of atrial fibrillation in
patients treated with Corlanor® compared to placebo was
5% vs. 3.9% per patient-year, respectively.
- Bradycardia and Conduction Disturbances: Bradycardia,
sinus arrest and heart block have occurred with
Corlanor®. Concurrent use of verapamil or diltiazem also
increases Corlanor® exposure and should be avoided.
Avoid use of Corlanor® in patients with 2nd
degree atrioventricular block unless a functioning demand pacemaker
is present.
- Adverse Reactions: The most common adverse drug
reactions in the SHIFT study occurring in ≥ 1% higher on
Corlanor® than placebo were bradycardia (10% vs. 2.2%),
hypertension or increased blood pressure (8.9% vs. 7.8%), atrial
fibrillation (8.3% vs. 6.6%), and luminous phenomena (phosphenes)
or visual brightness (2.8% vs. 0.5%).
Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436)
regarding Corlanor availability or find out more information,
including full Prescribing Information and Medication Guide, at
www.amgen.com.
About Amgen Cardiovascular
Building on more than three decades of experience in developing
biotechnology medicines for patients with serious illnesses, Amgen
is dedicated to addressing important scientific questions to
advance care and improve the lives of patients with cardiovascular
disease, the leading cause of morbidity and mortality
worldwide.6 Amgen's research into cardiovascular
disease, and potential treatment options, is part of a growing
competency at Amgen that utilizes human genetics to identify and
validate certain drug targets. Through its own research and
development efforts, as well as partnerships, Amgen is building a
robust cardiovascular pipeline consisting of several
investigational molecules in an effort to address a number of
today's important unmet patient needs, such as high cholesterol and
heart failure.
About Amgen
Amgen is committed to
unlocking the potential of biology for patients suffering from
serious illnesses by discovering, developing, manufacturing and
delivering innovative human therapeutics. This approach begins by
using tools like advanced human genetics to unravel the
complexities of disease and understand the fundamentals of human
biology.
Amgen focuses on areas of high unmet medical need and leverages
its biologics manufacturing expertise to strive for solutions that
improve health outcomes and dramatically improve people's lives. A
biotechnology pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Forward-Looking
Statements
This news release contains forward-looking statements that are
based on management's current expectations and beliefs and are
subject to a number of risks, uncertainties and assumptions that
could cause actual results to differ materially from those
described. All statements, other than statements of historical
fact, are statements that could be deemed forward-looking
statements, including estimates of revenues, operating margins,
capital expenditures, cash, other financial metrics, expected
legal, arbitration, political, regulatory or clinical results or
practices, customer and prescriber patterns or practices,
reimbursement activities and outcomes and other such estimates and
results. Forward-looking statements involve significant risks and
uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission (SEC)
reports filed by Amgen, including Amgen's most recent
annual report on Form 10-K and any subsequent periodic reports on
Form 10-Q and Form 8-K. Please refer to Amgen's most
recent Forms 10-K, 10-Q and 8-K for additional information on the
uncertainties and risk factors related to our business. Unless
otherwise noted, Amgen is providing this information as
of April 15, 2015 and expressly disclaims any duty to update
information contained in this news release.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for us
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
variability in the future. We develop product candidates internally
and through licensing collaborations, partnerships and joint
ventures. Product candidates that are derived from relationships
may be subject to disputes between the parties or may prove to be
not as effective or as safe as we may have believed at the time of
entering into such relationship. Also, we or others could identify
safety, side effects or manufacturing problems with our products
after they are on the market. Our business may be impacted by
government investigations, litigation and products liability
claims. We depend on third parties for a significant portion of our
manufacturing capacity for the supply of certain of our current and
future products and limits on supply may constrain sales of certain
of our current products and product candidate development.
In addition, sales of our products are affected by the
reimbursement policies imposed by third-party payors, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
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usage and pricing of our products. In addition, we compete with
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well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against
products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with our products. In addition, while we
routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors and
there can be no guarantee of our ability to obtain or maintain
patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful
products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, the discovery of
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that implicate an entire class of products could have a material
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achieve anticipated benefits and savings from our recently
announced restructuring plan. Our business performance could
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dividend or their ability to pay a dividend or repurchase our
common stock.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Cuyler Mayer, 805-447-6332
(media)
Arvind Sood, 805-447-1060
(investors)
References
- Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and
stroke statistics – 2015 update: a report from the American Heart
Association. Circulation. 2015;131:e29-e332.
- Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline
for the Management of Heart failure: A Report of the American
College of Cardiology Foundation/American Heart Association Task
Force on Practice Guidelines. Circulation.
2013;128:e240-e327.
- Swedberg K, Komajda M, Bohm M, et al. Ivabradine and Outcomes
in Chronic Heart failure (SHIFT): a Randomised Placebo Controlled
Study. Lancet. 2010; 376:875-85.
- Heidenriech PA, Albert NM, Allen
LA, et al. Forecasting the impact of heart failure in
the United States: a policy
statement from the American Heart Association. Circ Heart
Fail. 2013;6:606-619.
- Corlanor® U.S. Prescribing Information.
- World Health Organization. Cardiovascular diseases (CVDs) fact
sheet. http://www.who.int/mediacentre/factsheets/fs317/en/.
Accessed April 2015.
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SOURCE Amgen